Heart disease

Displaying 199 studies

  • A Study of the Effect of Exercise on Cardiac Hemodynamics After Adjusting Atrial-Ventricular and Interventricular Timing Delays in Patients with a CRT (Cardiac Resynchronization Therapy) Device Rochester, MN

    The purpose of this study is to determine the resuts of adjusting atrial-ventricular (AV) and interventricular (VV) timing delays on cardiac hemodynamics at rest and during exercise for patients who have a CRT (cardiac resynchronization therapy) device. Most current attempts to optimize CRT are done under resting conditions and patients report symptoms during mild daily exercise.

  • Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects With Elevated Risk Scottsdale/Phoenix, AZ

    The primary hypothesis is that additional LDL-C lowering with Evolocumab (AMG 145) when used in addition to other treatment for dyslipidemia is well tolerated and decreases the risk of cardiovascular death, myocardial infarction, hospitalization for unstable angina, stroke, or coronary revascularization in subjects with clinically evident cardiovascular disease.

  • Superficial Cervical Plexus Block for Pacemaker Insertion Jacksonville, FL

    The purpose of this study is to investigate clinical outcomes from two current standard of care pain control procedures performed for patients undergoing pacemaker insertion.

  • Diet, Vascular Health and the Gut Microbiome in Heart Failure Scottsdale/Phoenix, AZ

    Heart failure with reduced ejection (HFrEF) is a major health concern. HFrEF is associated with significant endothelial dysfunction (ED). The purpose of this study is to compare the effects of a Western diet (WD) to a high-carbohydrate, high-fiber diet (HCHF) on endothelial function in patients with HFrEF. the study will look at the distribution of intestinal microbe communities after following the diets as well as explore relationships between gut health and ED in patients with HFrEF.

    We propose to address this important gap in the literature with a study design that is responsive to needs in the area of healthcare delivery and ...

  • Beta-Blockers and Bone Health No Locations

    The proposed study will directly examine whether bone mineral density (BMD) and bone microstructure are better preserved among HF patients on chronic β-blockers and account for the reports of decreased fracture. 

  • Gene Polymorphisms in Cardiovascular Health and Disease Rochester, MN

    The purpose of this study is because we are testing the variation in a gene that may influence receptors in your heart, blood vessels and lungs.

  • Myocardial Infarction Genes (MI-GENES) Study Rochester, MN

    This study is being done to better understand how genetic information might improve assessment of heart attack risk.

  • Hospital Admission in Heart Failure: Readiness for Discharge and Predicting Future Admissions Rochester, MN

    The purpose of this study is to identify measures of heart rate and heart rate variability responses to changes in nervous system activity, breathing variability, and lung fluid in HF patients as early as possible in the course of their hospital admission and subsequently just prior to discharge, using a simplified approach, in order to determine if these measures can assess readiness for discharge and more accurately predict likelihood for readmission.

  • A Study to Compare the Rate of Major Cardiovascular Implantable Electronic Device Infections with the Absorbable Antibacterial Envelope and without Rochester, MN

    The purpose of this study is to evaluate the ability of the TYRX Absorbable Antibacterial Envelope to reduce major cardiovascular implantable electronic device infections through 12-months post-procedure following  generator replacement, upgrade, revision, or new CRT-D implant.

  • A Study to Evaluate Electrocardiogram and Heart Disease in Women Jacksonville, FL

    The purpose of this study is to determine the feasibility and effectiveness of electrocardiogram (ECG) to detect a form of heart failure among women of childbearing age (ages 18-49 years). 

    Heart disease is the leading cause of mortality during peripartum and postpartum period. Screening for heart disease during pregnancy, however, is a significant unmet need. If proven to be effective, this test can be used as a screening tool for early detection of heart failure among women who are contemplating pregnancy, currently pregnant or recently delivered a child. 

  • FAITH! Heart Health+ Minneapolis, MN; Rochester, MN

    The purpose of this study is to explore the biopsychosocial pathway between the social determinants of health, stress and structural racism and cardiovascular health (CVH) among African Americans.

    The social determinants of health, stress and structural racism will influence the ability of African-Americans to achieve ideal cardiovascular health (CVH) as defined by the American Heart Association Life’s Simple 7 (AHA LS7).

  • Contrast-Enhanced MR Angiography Method in Comparison to Current Methods in Healthy Volunteers Rochester, MN

    The purpose of this study is to look at a contrast-enhanced MR angiography method in comparison to current methods. The contrast-enhanced method can generate images with more spatial detail and can be used to view a much larger region of the patient’s body than is presently possible.

  • A Study to Evaluate Adipose Tissue for Regenerative Medicine Research in Cardiovascular Disease Jacksonville, FL

    The purpose of this study is to obtain adipose tissue from patients undergoing vascular surgery where EVs can be isolated from the fat and used for research purposes to examine their effect on inflammation and remodeling in culture and in animal models. The samples will immediately be processed to obtain EVs for research purposes - this is not a biorepository. 

  • A Study to Evaluate Potential Myocardial Injury Following Magnetic Resonance Imaging (MRI) Rochester, MN

    The purpose of this study is to prospectively determine if magnetic resonance imaging (MRI) in patients with cardiac implantable electronic devices (CIED) results in myocardial injury as assessed by changes in high sensitivity cardiac troponin T (hs-cTnT) assay. This will be done by comparing pre-and-post MRI hs-cTnT levels in these patients.

  • A Study to Assess the Effect of Lower Hemoglobin Levels on Cardiac Functions in Patients with Cardiac Diseases Rochester, MN

    The purpose of this study is to test if a reduction of hemoglobin leads to subclinical cardiac dysfunction in patients with known cardiovascular disease.

  • CIMT and Plaque Assessment Findings in Subjects Undergoing Stress Echocardiography for Risk Stratification Scottsdale/Phoenix, AZ

    The purpose of this research study is to determine if carotid artery ultrasound scanning can provide additional information for determining cardiovascular risk in patients.

    Patients who agree to participate wil undergo non-invasive carotid intima-media thickness (CIMT) measurement and plaque assessment. Findings of CIMT will be compared to results of patient standard of care stress echocardiogram (SE) and of diastolic function.

    We hypothesize tht 1) in patients undergoing SE for inappropriate or uncertain indications, CIMT and plaque assessment will provide useful risk stratification beyond use of traditional risk factors; 2) CIMT findings will correlate with results of SE in ...

  • Cardiovascular Health Promotion Among African-Americans by FAITH! Rochester, MN

    Given the importance of healthy lifestyle practices to cardiovascular disease (CVD) prevention and the utility of church-based interventions in African-American adults, the investigators developed a theory-informed, strategically-planned, health and wellness intervention with Rochester, Minnesota (MN) and Twin Cities area (Minneapolis, St. Paul, MN) churches with predominately African-American congregations. The objective of the study was to partner with churches to implement a multi-component, health education program through the use of core educational sessions delivered through a digital-application accessible on demand via interactive access on computer tablets and the Internet. The overarching goal was to increase the awareness and critical importance of ...

  • A Study of Ultrasound Shear Wave Elastography to Assess Heart Muscle Stiffness for Patients with Diastolic Heart Failure Rochester, MN

    The purpose of this study is to investigate the use of shear wave elastography to assess diastolic heart muscle stiffness for diastolic heart failure patients, and compare the stiffness measurements with the cardiac catheterization (cath lab) results.

  • Using Exercise Testing to Measure the Benefits of Cardiac and Pulmonary Rehabilitation Jacksonville, FL

    Cardiopulmonary rehabilitation (CP rehab) with an exercise component is important in the care from many people with heart or lung disease. Measuring the benefits of CP rehab (i.e., measuring ‘how well CP rehab works’) depends upon having tests or ‘tools’ that can very well detect positive changes in physical and clinical function. One such tool is maximal cardiopulmonary exercise testing (CPET). This is the gold standard for measuring exercise capacity. However, maximal CPET is expensive, has extensive set-up and space requirements, needs direct medical supervision, and involves interpretive complexity; these factors have limited the widespread use of maximal ...

  • A Study to Determine the Impact of Individualized Estrogen Therapy on Cardiovascular Disease Risk Parameters in Young Women after Bilateral Oophorectomy Rochester, MN

    The purpose of this study is to compare the cardiovascular function in young women (<46 years)="" following="" bilateral="" oophorectomy="" who="" are="" treated="" with="" either="" the="" standard="" dose="" of="" estradiol="" (100="" mcg="" transdermal="" patch="" or="" equivalent="" oral="" dose)="" or="" titrated="" estradiol="" dosing="" to="" achieve="" average="" premenopausal="" estradiol="" level="" (80-120="" pg/ml),="" to="" characterize="" the="" relationship="" between="" the="" serum="" estradiol="" level="" and="" cardiovascular="" function="" in="" young="" women=""><46 years) on estradiol replacement after bilateral oophorectomy, and to compare the body composition in young women following bilateral oophorectomy who are treated with either the standard dose of estradiol (100 mcg transdermal patch or equivalent ... years)="" on="" estradiol="" replacement="" after="" bilateral="" oophorectomy,="" and="" to="" compare="" the="" body="" composition="" in="" young="" women="" following="" bilateral="" oophorectomy="" who="" are="" treated="" with="" either="" the="" standard="" dose="" of="" estradiol="" (100="" mcg="" transdermal="" patch="" or="" equivalent="" ...="">

  • EKO Duo Device in Patients with Genetic Heart Diseases Rochester, MN

    The purpose of this study is to evaluate diagnostic accuracy of the EKO DUO System in patients with Genetic Heart Diseases and develop novel algorithms to diagnose these conditions. The device will be placed on the chest (similar to a stethoscope exam) and will simultaneously record an ECG and phonocardiogram (PCG) for up to 120 seconds. Additional data obtained will include clinical characteristics, past medical history, recent medications and procedure, laboratory data, and echocardiographic and ECG studies.

    Tools like the EKO Duo device can be used to improve diagnosis and risk stratification in patients with genetic heart diseases (GHDs).

  • Evaluation of Major Cardiovascular Events in Patients With, or at High Risk for, Cardiovascular Disease Who Are Statin Intolerant Treated With Bempedoic Acid (ETC-1002) or Placebo La Crosse, WI

    The purpose of this study is to determine if treatment with bempedoic acid (ETC-1002) versus placebo decreases the risk of cardiovascular events in patients who are statin intolerant.

  • Cardiopulmonary Exercise Testing as a Tool for Cardiac Screening Pre-Transplant Scottsdale/Phoenix, AZ

    The purpose of this study is to determine the change in exercise capacity by comparing VO2 max results pre & post renal transplant.

       

  • ECG Patch for Monitoring Potassium Levels in Patients with Cardiac and Renal Disease Rochester, MN

    The purpose of this study is to refine the technique for non-invasively determined potassium measurement and to determine whether or not the technique can be realized in a single channel-subcutaneous ECG implementation modality.

  • Effects of Chardonnay Seed Flour on Vascular Health Rochester, MN

    This is a randomized, double-blinded trial (Chardonnay seed flour vs. placebo - in pill form) with the purpose to test the impact of a four-month supplementation with Chardonnay Seed Flour (CSF) on endothelial function. Chardonnay flour is made from wine grape skins and seeds. We will examine the effect of CSF on parameters such as endothelial function (via EndoPAT testing), plasma lipid levels, glucose tolerance, insulin resistance, inflammatory markers, oxidative stress surrogates, endothelial progenitor cells (EPCs) as well as the makeup of and impact on the gut microbiome (via stool samples).

  • Routine Hemodynamic Monitoring following Percutaneous Coronary Interventions Rochester, MN

    We will identify the prevalence of hemodynamic abnormalities following percutaneous coronary interventions (PCI). Second, among patients with hemodynamic problems, we will be able to identify problems for which action needs to be taken. Third, pursuant to the results of our study, we can identify the clinical utility of such monitoring and will be able to target such monitoring to at-risk patients and will likely obviate the need for routine monitoring, propose cost-effectiveness measures, and propose same day discharge on low-risk patients.

  • A Study of Stress Management Intervention in a Women's Heart Clinic, The Heart SMART Program Rochester, MN

    The purpose of this study is to see how usefull will the Heart SMART program be in moderate or high stress patients who are referred to the Women's Heart and Preventive Cardiology clinics at Mayo Clinic.

  • Cardiovascular Effects of Energy Drinks in Healthy Adults Rochester, MN

    This study is being done to look at the cardiovascular response, if any, to intake of commercially available energy drink. We hypothesize that energy drink consumption compared to a control drink in healthy adults alters the cardiovascular hemodynamic system.

  • Study of High-dose Spironolactone vs. Placebo Therapy in Acute Heart Failure Rochester, MN

    The primary objective of this study is to test the hypothesis that high-dose spironolactone will lead to greater proportional reduction in NT-proBNP levels from randomization to 96 hours over standard of care.

  • Ultrasound-based Technology (similar to standard clinical echocardiography) for Measuring the Stiffness of Heart Muscle and Peripheral Arteries Rochester, MN

    The purpose of this study is for evaluating an ultrasound-based technology (similar to standard clinical echocardiography) for measuring the stiffness of your heart muscle and your peripheral arteries. This type of information may prove to be clinically important.

  • Integrated Tele-monitoring and Patient-centric Health Coaching Strategy in Patients Hospitalized With Heart Failure La Crosse, WI; Eau Claire, WI; Jacksonville, FL

    This study evaluates the effectiveness of remote tele-monitoring and health coaching in helping to reduce hospitalizations in heart failure patients. Half of participants will receive tele-monitoring and health coaching, while the other half will receive standard health care provided by their chosen provider.

  • The Ventilatory Response to Activation of the Locomotor Afferents in Normoxic and Hypoxic Conditions Rochester, MN

    The purpose of this study is two-fold. The first purpose is to understand how feedback from your muscles can change ventilation at rest and during exercise in low and high oxygen conditions. The second purpose is to understand how feedback from your muscles can influence muscle fatigue and muscle function in normal and low oxygen conditions. The ventilatory response to exercise and skeletal muscle fatigability in healthy controls and HF patients will advance our understanding of tolerance to exercise in HF patients.

  • Barriers to Cardiac Rehabilitation Rochester, MN

    The purpose of this study is to assess barriers to completion of cardiac rehabilitation program and to identify potential ways to improve cardiac rehabilitation completion.

  • Reducing CVD Risk in African Americans Faith Communities Rochester, MN

    The ultimate goal of our partnership with local African-American churches is to implement an effective, multi-component intervention to increase awareness of the critical importance of healthy lifestyle in the prevention of cardiovascular disease (CVD). We will utilize the American Heart Association (AHA) prevention strategy, "Life's Simple 7" to address the major risk factors for CVD: diet, smoking, physical inactivity, hypertension, diabetes, cholesterol and obesity in order to improve overall cardiovascular health. Our main strategy consists of a community-based participatory research approach that involves focus groups to assess participant knowledge and beliefs about CVD risk factors prior to program initiation. We ...

  • A Study of the Role of the Forkhead Box O3a BNIP3 Pathway in Human Cardiovascular Disease Rochester, MN

    The purpose of this study is to collect cardiac biopsies and assess the activity of the signaling pathway in patients with cardiovascular disease by  using transmission electron microscopy to study mitochondrial structure and morphology and by assessing the biology of the genes and proteins of the FOXO3a effector, BNIP3.

  • Cardiovascular Surgery Biobank Rochester, MN

    Researchers in the Division of Cardiovascular Surgery at Mayo Clinic are developing a new research resource called the "Cardiovascular Surgery Biobank" (hereafter referred to as the "Biobank". Participants in the Biobank allow investigators at the Mayo Clinic to obtain diseased tissue that is removed during cardiovascular surgery, and allow access to medical records for research now and in the future. The Biobank serves as a resource for researchers in cardiovascular disease; instead of having to wait for months or years for tissue to be accumulated, researchers can use samples from the Biobank that were normally removed as a part of ...

  • Improving Wellbeing in Ischemic Heart Disease Jacksonville, FL

    The overarching aim of this project is to evaluate the impact of adding a novel digitally-delivered wellbeing intervention, namely the Heart Health Yoga (HHY) program, on overall wellbeing and quality of life (QoL), cardiovascular risk markers, adherence to therapy, sleep quality, and recurrent hospitalizations amongst ischemic heart disease (IHD) patients undergoing cardiac rehabilitation (CR).

  • Using Quantitative Measures to Determine the Effectiveness of Standard of Care Preventative Treatments for Cardiovascular Disease in the Homeless Jacksonville, FL

    The purpose of this study is to determine the effectiveness of intensive, guideline-directed, preventative therapies on cardiovascular disease in the homeless population to help develop an appropriate care model for preventing and treating CVD in the homeless.

     


     

  • A Study to Compare the Effectiveness of an Invasive Treatment Approach versus Conservative Medication Alone Strategy for Patients with Stable Ischemic Heart Disease Jacksonville, FL

    The purpose of this study is to determine if an initial invasive strategy of cardiac catheterization and optimal revascularization with optimal medical therapy is the best management strategy compared with an initial conservative strategy of optimal medical therapy alone for higher-risk patients with stable ischemic heart disease.

  • A Study to Improve Cardiovascular Health Among African Americans within Faith Communities Rochester, MN

    The purpose of this study is to apply a community-based participatory research (CBPR) approach to rigorously refine and test the feasibility and preliminary effectiveness of our existing cardiovascular (CV) health and wellness digital application (app) prototype to improve CV health according to the American Heart Association Life’s Simple 7 (LS7) framework among African-American (AA) adults within faith communities.

  • A Study to Understand the Perceptions of Patients, Family Members and Caregivers About Their Role for Engagement in Research Rochester, MN

    The purpose of this study is to get input from a focus group to understand the interests and perceptions of patients, family members, and caregivers about their role for engagement in the conducting of research related to their medical conditions.

  • Understanding Return to Play for Athletes with Cardiovascular Disease Rochester, MN

    The purpose of this study is to understand the logistical aspects and the barriers that athletes with cardiovascular disease have faced in the process of returning to play, to understand the decision-making process that occurs among athletes, their families, medical professionals, and the school/club administration in choosing to return to the field, and to understand the contingency/emergency plans in the athletes who returned to play.

  • A Study to Evaluate Electrocardiogram Artificial Intelligence-Guided Screening for Low Ejection Fraction (EAGLE) Rochester, MN

    The purpose of this study is to prospectively evaluate a newly-developed screening tool for ALVSD.

  • Patients With Patent Foramen Ovale and Endocardial Device Leads on Apixaban for Prevention of Paradoxical Emboli Rochester, MN

    Patients with a patent foramen ovale in the setting of endocardially placed cardiac implantable electronic devices such as pacemakers, defibrillators, or resynchronization therapies are likely at higher risk for paradoxical embolic events from device lead thrombus. The investigators are conducting this study to determine if the anticoagulant medication Apixaban is more effective at reducing MRI detected brain lesions compared to placebo.

  • A Study to Assess Measurements in Cardiomyopathy Patients Using Software for Multi-level Reconstruction of Three Dimensional Transesophageal Echocardiography (TEE) or Transthoracic Echocardiography (TTE) Images Rochester, MN

    The purpose of this study is to utilize three dimensional (3D) transesophageal echocardiography (TEE) or 3D transthoracic echocardiography (TTE) to measure various mitral chordal, annular, and leaflet measurements and LV size to better understand the mechanism of regurgitation in patients with FMR.

  • Ranolazine for Incomplete Vessel Revascularization Post-Percutaneous Coronary Intervention (PCI) No Locations

    This study will evaluate the efficacy of ranolazine as compared with placebo when used as part of standard medical therapy in chronic angina subjects with incomplete revascularization post-PCI on the composite of ischemia-driven revascularization or ischemia-driven hospitalization without revascularization.

  • Registry of Efficacy and Safety of Non-vitamin K Antagonist Oral Anticoagulants for Thromboembolic Prevention in Patients with Congenital Heart Disease Rochester, MN

    The purpose of this study is to explore the potential role of NOAC as an alternative therapy in the congenital heart disease population.

  • A Study of Biomarkers for Human Heart Failure Rochester, MN

    The purpose of this study is to attempt to establish the various ranges of proteins that can be assayed from the plasma and urine of patients with all classes of heart failure and MI (myocardial infarction).

  • Lp-PLA2 and Coronary Atherosclerosis in Humans Rochester, MN

    The majority of the acute coronary events are caused by coronary artery segments with minimal luminal disease, but with potentially significant vascular wall inflammation and oxidative stress leading to plaque vulnerability. It has become apparent that an initial injury at the endothelial surface, is the primary site of the mechanisms involved and a role for vascular inflammation and the interaction with oxidative stress continues to emerge. Lipoprotein-associated phospholipase A2 (Lp-PLA2) is a novel biomarker for vascular wall inflammation that circulates in the blood bound to both low density (LDL) and high density (HDL) lipoprotein and promotes vascular inflammation. Circulating levels ...

  • New Methods to Diagnose Constrictive Pericarditis Rochester, MN

    Until now, diagnosis of constriction was based on pressure changes of ventricle by conventional pressure-wide hemodynamic evaluation but not on ventricular volume change. This study will provide answers to persisting questions about volume changes during respiration in patients with constrictive pericarditis by directly measuring both right and left ventricular volume.

  • Accelerated Stem Cell Senescence in Heart Failure Rochester, MN

    The purpose of this study is to study circulating progenitor cells in human subjects with heart failure and before and after LVAD therapy.

  • Myocardial Ischemia and Transfusion Rochester, MN

    The purpose of this study is to compare two red blood cell transfusion strategies (liberal and restrictive) for patients who have had an acute myocardial infarction and are anemic.

  • A Study of Allopurinol to Relieve Symptoms in Patients with Heart Failure and High Uric Acid Levels Albert Lea, MN; Rochester, MN

    The purpose of this study is to determine if allopurinol is effective in relieving symptoms for patients who have heart failure and high blood uric acid levels.

  • A Study of the Safety and Effectiveness of NEOD001 for Treating Previously Treated Patients with Persistent Cardiac Dysfunction Related to Light Chain Amyloidosis Jacksonville, FL; Rochester, MN

    The purpose of this study is to assess the effectiveness and safety of NEOD001 administered intravenously in adults with light chain amyloidosis who have had a hematologic response to previous treatment for their amyloidosis (e.g., chemotherapy, autologous stem cell transplant [ASCT]) and have persistent cardiac dysfunction.

  • Olive Oil and Cardiovascular Health Rochester, MN

    The purpose of this study is to conduct a double-blind, randomized controlled trial (RCT), to determine if six month supplementation of olive oil can improve the health of the blood vessels and improve long term health of the heart and blood vessels, in patients requiring percutaneous coronary intervention (PCI).

  • Is Our Microbiome a Predictor of Cardiac Risk Rochester, MN

    The purpose of this study is to compare the fecal microbiota of patients with mild, moderate and severe Coronary Artery Disease (CAD) by collecting stool and blood samples from patients undergoing coronary angiograms.

     

  • Hypothalamic Amenorrhea as a Fertility Status Marker for Cardiovascular Health (ARCH) Jacksonville, FL

    The purpose of this study is to use innovative remote patient monitoring and patient reported outcomes to investigate Hypothalamic Amenorrhea (HA) specific phenotype(s) related to cardiovascular disease (CVD) (and vascular inflammation).

     

  • A Study to Evaluate Interactions Between Hormones and the Nervous System Rochester, MN

    The purpose of this study is to test the hypothesis that obesity is associated with impairment of cardiovascular reflex control, and that this impairment is linked to deficient leptin activity.

  • COMPASSION S3 Post-Approval Study Rochester, MN

    The purpose of this study is to monitor device performance and outcomes of the SAPIEN 3 Transcatheter Heart Valve (THV) System in subjects with a dysfunctional right ventricular outflow tract (RVOT) conduit or previously implanted surgical valve in the pulmonic position with a clinical indication for intervention.

  • Stress Echocardiography in Mixed and Multi Valvular Heart Disease Rochester, MN

    The purpose of this study is to: investigate the diagnostic utility of stress echocardiography (SE) in the evaluation of patients with mixed and mult-valvular heart disease (mx/ml-VHD), evaluate the hemodynamic impact of exercise on mx/ml-VHD compared to those with isolated valve disease, study the prevalence and natural history of mx/ml-VHD, and identify clinical, echocardiographic and biochemical markers that can be used to identify patients with mx/ml-VHD who are at higher risk for future cardiovascular events.

  • A Study of Biomarkers to Predict Cancer Therapy-related Cardiotoxicity Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN

    The primary purpose of this study is to collect Biospecimens from patients who developed chemotherapy related cardiac toxicity (CRCT) and patients who are at a high risk for developing CRCT identified prior to the onset of therapy.

  • Clinical Evaluation of the CADence Device in Detection of Coronary Artery Diseases Rochester, MN

    This is a multi-center, prospective, non-randomized, double-blinded trial to evaluate the performance of the CADence device in detecting the existence of clinically significant coronary artery disease.

  • Stress Echo for Patients with Congenital Heart Disease Rochester, MN

    The primary purpose of this study is to compare the difference in the ability to detect hemodynamic abnormalities between echocardiographic assessments performed at rest versus exercise. 

     

  • Screening for PPCM Using AI Jacksonville, FL; Rochester, MN

    The overall goal of this study is to investigate the use of artificial intelligence (AI) techniques as a screening tool for cardiomyopathies in pregnancy and the post-partum period.

     

  • Comparison of Short and Long-Term Outcomes between Surgical Septal Myectomy and Alcohol Septal Ablation Rochester, MN

    The standard of care for obstructive hypertrophic cardiomyopathy (HCM) refractory to medical therapy is surgical septal myectomy. Percutaneous transluminal septal myocardial ablation, otherwise known today as alcohol septal ablation (ASA) has been growing as a favorable alternative to myectomy. There have been no randomized controlled trials conducted to evaluate ASA versus surgical myectomy. The purpose of this study is to compare overall survival between surgical septal myectomy and alcohol septal ablation. The study will also compare periprocedural and long-term complication rates for both myectomy and alcohol septal ablation. Furthermore, the study willl determine the rates of re-intervention for both myectomy ...

  • Lp-PLA2, Progenitor Cells and Coronary Atherosclerosis in Humans AIM III Rochester, MN; Rochester, MN

    AIM III is a prospective, randomized, double-blinded, placebo controlled trial. The study is directly connected to IRB 08-008161 as a specific aim of the National Institute of Health (NIH) grant. Participants may either consent to and qualify for AIM I and AIM II (IRB 08-008161) or have a cardiac catheterization with acetylcholine testing in the Cardiac Catheterization Laboratory at Mayo Clinic in Rochester MN to be considered for this study.

  • A Study to Evaluate the Impact of Menopause on Cardiac Stiffness Acquired with Magnetic Resonance Elastography Rochester, MN

    The purpose of this study is to evaluate the effects of menopause transition on myocardial stiffness in healthy female subjects without a history of heart disease who are expected to be close to the average age of menopause transition (~51 years), in the 48-53 year age range. All eligible subjects will undergo two study visits that will include a cardiac MRI/MRE exam, echocardiography imaging and blood test.

    The purpose of this aim is to characterize the relationship between the serum estradiol level and myocardial stiffness changes in young women (<46) on estradiol replacement therapy after bilateral oophorectomy.  Subjects will be ...

  • Exercise and Low-Dose Rapamycin in Older Adults with CAD:Cardiac Rehabilitation And Rapamycin in Elderly (CARE) Trial Rochester, MN

    The investigators will do the study in two phases. The first phase will be a pilot study on up to 18 participants [patients 60 years or older with coronary artery disease (CAD) undergoing percutaneous coronary intervention (PCI) or coronary artery bypass surgery (CABG) or patients who are eligible to undergo and participate in cardiac rehabilitation (CR)]; up to 6 participants each will be given oral daily rapamycin (0.5, 1, and 2mg) dose for the duration of CR. Baseline and follow-up data will be collected for age-associated impairment (AAI): frailty (primary endpoint) and quality of life (QOL),senescent-associated secretory phenotype (SASP)and abdominal/thigh ...

  • A Research Study to Look at How a New Medicine Called NNC6019-0001 Works and How Safe it is for People Who Have Heart Disease Due to Transthyretin (TTR) Amyloidosis Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN

    The purpose of this study is test the effectiveness and safety of NNC6019-0001 to determine if it can reduce the symptoms of a heart disease due to TTR (Transthyretin ) amyloidosis, such as heart failure.  

  • Cardio-Oncology Clinic Registry Rochester, MN

    The purpose of this study is to establish a retrospective and prospective clinical registry of patients seen in the cardio-oncology clinic to characterize trends in the composition and outcomes of the population seen in the clinic, as well as initial clinical analyses on cardiovascular toxicities.

  • Healthy Immigrant Community: Mobilizing the Power of Social Networks Rochester, MN

    The objective of this study is to leverage existing social networks for health behavior change relevant to obesity and cardiovascular risk among immigrant populations in Southeast MN.

  • A Study of Cardiovascular Risk Factors in Transgender Children and Youth Rochester, MN

    The purpose of this study is:

    • Specific Aim 1:  To determine the prevalence of obesity, cardiometabolic risk factors and mental health diagnoses among transgender children and adolescents evaluated at the Mayo clinic Transgender and Intersex Specialty Care Clinic (TISCC)
    • Specific Aim 2:  To measure adipokines related to energy homeostasis and insulin sensitivity in transgender children and adolescents and compare with those in cisgender age and gender matched controls.

  • ABSORB III Randomized Controlled Trial (RCT) Rochester, MN

    The ABSORB III RCT is a prospective randomized, single-blind, multi-center trial. It is the pivotal trial to support the US pre-market approval (PMA) of Absorb™ Bioresorbable Vascular Scaffold (BVS).

    The ABSORB III includes additional two trials i.e. ABSORB III PK sub-study and ABSORB IV RCT trial which are maintained under one protocol because both trial designs are related, ABSORB IV is the continuation of ABSORB III and the data from ABSORB III and ABSORB IV will be pooled to support the ABSORB IV primary endpoint. Both the trials will evaluate the safety and effectiveness of Absorb BVS.

  • Determining the Natural and "Unnatural" History of Anomalous Aortic Origin of a Coronary Artery with an Interarterial or Intraconal or Intermural Course (AAOCA): Establishing a Multi-Institutional Registry Rochester, MN

    The purpose of the study is to determine the outcome of surgical intervention versus observation in children and young adults with AAOCA. To do this the plan is to create a registry of AAOCA subjects that will enable us to develop a risk stratification model utilizing a large multi-institutional registry under the auspices of the Congenital Heart Surgeons’ Society (CHSS).

  • OPTIMIZE IDE for the Treatment of ACS Rochester, MN

    Indication for use: "The Svelte DES is indicated for improving coronary luminal diameter in patients with symptomatic heart disease, including patients with non-ST elevation MI due to discrete de novo native coronary artery lesions. The treated lesion length should be less than the nominal stent length with a reference vessel diameter of 2.50 mm - 4.00 mm

  • Continued Access to PREVAIL (CAP2) Rochester, MN

    To provide additional information about the safety and efficacy of the WATCHMAN LAA Closure Technology.

  • Long Term Follow Up Study of the St. Jude Medical Trifecta Valve Rochester, MN

    The purpose of this study is to collect long term follow up study data of the Trifecta valve in subjects who had the Trifecta valve implanted during the IDE study.

  • TOCCASTAR - TactiCath Contact Force Ablation Catheter Study for Atrial Fibrillation No Locations

    The TOCCASTAR Study will assess the safety and effectiveness of a contact force sensing catheter used for ablation in patients with paroxysmal atrial fibrillation. Subjects will be randomized for treatment with either the TactiCath catheter or another ablation catheter with no contact force sensing capability. Patients will be followed for 12 months to compare the incidence of serious adverse events and freedom from recurring, symptomatic AF between the two study arms. Additional measures of treatment success including quality of life, recurrence of asymptomatic AF and procedural efficiency will also be studied.

    A second phase of the study will treat up to ...

  • A Study Validating the "Foods for Health" Portfolio of Functional Food Products, for People Unable to take Statin Drugs Rochester, MN

    The purpose of this study is to evaluate the ability of a range of new, easy to use, proprietary food based products to affect cardiovascular disease (CVD) risk factors by positively impacting blood cholesterol levels in statin intolerant and/or statin unwilling participants.

  • Genotype-Phenotype Correlation in Cardiovascular Disease Rochester, MN

    This research study is being done to help characterize cardiovascular disease and improve diagnostic tests.

    OBJECTIVES

    1. To understand the pathogenesis, molecular mechanisms, and disease progression of heritable cardiovascular disease

    2. To evaluate the incidence of occult heritable cardiovascular disease in various populations.

    3. To correlate imaging and pathological phenotype with genotype to the ends described above.

  • A Study to Evaluate Sacubitril-Valsartan for Left Ventricular Reverse Remodeling in Adults with Congenital Heart Abnormality Rochester, MN

    The purpose of this study is to determine the optimal medical therapy to improve left ventricular (LV) function. Improvement in LV function has the potential to reduce the burden of heart failure and improve clinical outcomes in the Tetralogy of Fallot (TOF) population.

  • Analysis of Outcomes of Left Cardiac Sympathetic Denervation in Arrhythmia Syndromes and Cardiomyopathies Rochester, MN

    The purpose of this study is to collect and review the Mayo Clinic experience with left cardiac sympathetic denervation (LCSD) in patients with heritable arrhythmias syndromes or refractory ventricular arrhythmias beginning in 2000.

  • Cardiovascular Disease Specimen Repository Rochester, MN

    The purpose of the study is collect specimens for future studies to identify markers circulating in the blood that are associated with the development of further complications of heart disease.

  • Safety and Efficacy of ANX-042 in Human Cardiorenal Syndrome Rochester, MN

    The purpose of this study is to look at kidney function and hormonal function in patients with a history of heart failure and kidney dysfunction, and to see how the use of a new drug, ANX-042, affects those functions.

  • Mobile Monitoring of Children with Single Ventricle Congenital Heart Disease Rochester, MN

    The primary aim of this study is to create a streamlined home monitoring process with modern technologies that are both usable and efficient.  The overall objective of this study is to determine whether or not this application helps improve the efficiency of medical care teams while providing care to interstage participants through the use of usability metrics.  Secondarily, this study introduces a prioritization system that estimates the current risk profile of individual patients to help medical care teams better prioritize their weekly workflows.  Although this mobile application is not a mobile medical device according to the definition of the FDA ...

  • Screening for Pregnancy Related Heart Failure in Nigeria Jacksonville, FL; Rochester, MN

    The purpose of this studyis to determine the effectiveness of an AI-enabled ECG to detect cardiomyopathy and its impact on clinical outcomes in a predominantly Black obstetric population in Nigeria

  • Stroke Mitigation in A-fib Reasoning Tool for Shared Decision Making Rochester, MN

    The purpose of this study is to assist patients and clinicians weigh the potential harms and benefits of different treatment options for atrial fibrillation.  The plan is to develop an evidence-based decision aid for use in clinical encounters. The goal is to promote evidence-based patient-centered care. Ideally, this care should reflect the research evidence about treatment options for atrial fibrillation. It should also reflect the values and preferences of the informed patient.

  • Genetic Investigations in Hypoplastic Left Heart Syndrome Rochester, MN

    The primary objective of the study is to utilize comprehensive, family-centered genomic screening strategies - chromosomal microarray (CMA) and whole genome sequencing (WGS) - to discover the genetic bases for Hypoplastic Left Heart Syndrome (HLHS), a severe type of congenital heart disease characterized by underdevelopment of left heart structures.

  • A Study to Evaluate Heart Disease and Pulmonary Hypertension Voice Characteristics Rochester, MN

    The purpose of this study is to determine the association between patient voice signal characteristics and the presence and severity of pulmonary hypertension in patients referred for elective clinically indicated echocardiography for at Mayo Clinic MN.

  • Grit as a Predictor of Outcomes in Transcatheter Valvular Therapeutic Candidates No Locations

    The purpose of this study is to provide a survey to prospective candidates undergoing transcatheter valve replacement or repair at two time-points to assess grit, a psychological composite of personal diligence which has been validated to predict retention in other pursuits of long-term goals over and above assessments limited to intelligence and physical aptitude.

  • Registry for Mayo Clinic Adult Congenital Heart Disease Control Population Rochester, MN

    The purpose of this study is to provide all studies that contribute to the Mayo Clinic Adult Congenital Heart Disease (MACHD) Registry with a control cohort, this study will combine all testing needed for each of the studies. 

  • International Study of Comparative Health Effectiveness With Medical and Invasive Approaches (ISCHEMIA) No Locations

    The purpose of the ISCHEMIA trial is to determine the best management strategy for higher-risk patients with stable ischemic heart disease. This is a multicenter randomized controlled trial with a target enrollment of ~8000 patients with at least moderate ischemia on stress imaging. Patients will be assigned at random to a routine invasive strategy (INV) with cardiac catheterization (cath) followed by revascularization plus optimal medical therapy (OMT) or to a conservative strategy (CON) of OMT, with cath and revascularization reserved for those who fail OMT.

    SPECIFIC AIMS

    A. Primary Aim

    The primary aim of the ISCHEMIA trial is to ...

  • Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial Scottsdale/Phoenix, AZ

    Carotid revascularization for primary prevention of stroke (CREST-2) is two independent multicenter, randomized controlled trials of carotid revascularization and intensive medical management versus medical management alone in patients with asymptomatic high-grade carotid stenosis. One trial will randomize patients in a 1:1 ratio to endarterectomy versus no endarterectomy and another will randomize patients in a 1:1 ratio to carotid stenting with embolic protection versus no stenting. Medical management will be uniform for all randomized treatment groups and will be centrally directed.

  • Fat Biology, Sleep Disorders, and Cardiovascular Disease Rochester, MN

    Endothelial dysfunction, or abnormal functioning of the lining of blood vessels, appears to be a key process in the development of cardiovascular disease. Endothelial dysfunction appears to be caused by both sleep disordered breathing and obesity. As endothelial dysfunction is among the first clinical marker that predicts future cardiovascular events, understanding molecular mechanisms leading to impairment of endothelial function is very important. Endothelial function requires the proper functioning of endothelial nitric oxide synthase (eNOS). eNOS activity is tightly regulated by caveolin-1, a protein important in the formation of cellular structures called caveolae. Low levels of caveolin-1 facilitate optimal nitric oxide ...

  • Use of Cardiac Magnetic Resonance Imaging (cMRI) and Echocardiogram to Diagnose Constrictive Pericarditis and Restrictive Cardiomyopathy Rochester, MN

    The purpose of this study is to learn whether Cardiac Magnetic Resonance Imaging (cMRI) and/or echocardiogram is useful to diagnose patients with unique heart conditions. This research study focuses on evaluating the use of cMRI or echocardiogram as a novel, non-invasive method for evaluating specific heart conditions.

  • Bioengineered Cardiac Tissue for Hypoplastic Left Heart Syndrome Analysis Rochester, MN

    The purpose of this study is to produce and characterize patient-specific cardiac tissue for Hypoplastic Left Heart Syndrome (HLHS) using reprogrammed cell technology.

  • Perceval Sutureless Implant Vs Standard Aortic Valve Replacement: A Controlled Randomized Trial in the Surgical Treatment of Aortic Valve Disease Rochester, MN

    The primary objective of this trial is to test the safety and efficacy of Perceval versus standard sutured stented bioprosthetic aortic valves among the intended trial population.

  • A Noninvasive Monitor for the Detection of Preclinical Heart Failure in Children with Congenital or Acquired Heart Disease Rochester, MN

    The primary objective of this study is to determine whether a Mayo-developed, highly miniaturized physiologic monitoring instrument can provide early detection of heart failure (HF) in children with congenital or acquired heart disease at risk for or with evidence of heart failure (HF).

  • A Study to Investigate the Safety and Effectiveness of SAPIEN 3 Transcatheter Heart Valve Implantation in Patients with a Failing Mitral Bioprosthetic Valve Rochester, MN

    The purpose of this study is to assess the safety and effectiveness of the SAPIEN 3 (Edwards Lifesciences, Irvine, California) transcatheter heart valve in patients with a failing mitral bioprosthetic valve.

  • A Study to Evaluate Mitral Implantation of Transcatheter Valves Rochester, MN

    The purpose of this study is to enroll high surgical risk patients with severe mitral annular calcification (MAC) and symptomatic mitral valve disease. There are 2 arms in this study: Transseptal Valve-in-MAC (ViMAC) and a control arm of patients treated with medical treatment only which will include patients who can't be treated due to the presence of anatomical exclusion criteria or other exclusion criteria.

  • A Study to Assess the Biological Progression and Mechanisms of Mitral Annular Calcification Rochester, MN

    The purpose of this study is to test the hypothesis that Endothelial Progenitor Cells osteoblastic phenotype (EPC-OCNs) play a significant role in the process of Mitral Annular Calcification (MAC) as prognostic markers of calcific cardiac valves.

  • Get Going: Accelerometer-Based Intervention to Promote Physical Activity in Frail Older Adults La Crosse, WI; Rochester, MN

    A multicenter prospective randomized clinical trial testing the hypothesis that a patient-centered actigraphy intervention will result in increased physical activity for frail older adults increase during the critical first 30 days after a cardiovascular hospitalization.

  • A Study to Evaluate NT-proBNP Levels in the Prediction of Intrapartum and Postpartum Events in Adult Congenital Heart Disease Patients Rochester, MN

    The purpose of this study is to characterize the relationship between NT-proBNP levels obtained at time of admission for delivery and subsequent cardiovascular events in ACHD patients, and to describe normative values for NT-proBNP at time of admission for delivery in an uncomplicated obstetric population.

  • Autologous Induced Pluripotent Stem Cells of Cardiac Lineage Delivered Into Heart Muscle for Congenital Heart Disease Rochester, MN

    The purpose of this study to test the feasibility and safety for autologous (from your own body) skin cells that are manufactured into stem cells of cardiac lineage to be delivered into the heart muscle to determine if those stem cells will strengthen the heart muscle and can be used as an additional treatment for the management of  congenital heart disease. 

  • An International Registry for Data and Imaging of Children with Congenital Bicuspid Aortic Valve Disease Rochester, MN

    The purpose of this registry is to collect data and imagery, to study children and adults under the age of 21 who were born with bicuspid aortic valve disease. Some types of bicuspid aortic valves might be more likely associated with greater disease severity such as the degree of stenosis or valve leakage and possible enlargement of the aorta.

  • A Study of Atrial Cardiopathy and Antithrombotic Drugs In Prevention After Cryptogenic Stroke Jacksonville, FL

    The primary purpose of this study is to test the theory that Eliquis (apixaban) is superior to aspirin for the prevention of recurrent stroke in patients with cryptogenic ischemic stroke and atrial cardiopathy.

  • Cara CDRM (Conduction Disturbance Risk Monitor) 2.0 Rochester, MN

    The purpose of this study is to establish the safety of using Cara™ Monitor used in TAVR, and to estimate the effect of Cara Monitor on reduction of NOCD post TAVR compared to patients treated and followed per regular site-specific practice.

  • A Study of the Effects of Decreasing the Lasix Dose on the Cardiorenal System Rochester, MN

    The purpose of this study is to define the effects of decreasing the furosemide (lasix) dose on heart, kidney and biochemical balance, in people with compensated heart failure and kidney dysfunction and also in people with compensated heart failure without kidney dysfunction.

  • A Study to Understand the Extent of Routine Cardiovascular Screening in Patients with Rheumatoid Arthritis Rochester, MN

    The purpose of this study is to understand the extent of routine cardiovascular screening in patients with rheumatoid arthritis to improve management of their cardiovascular disease and optimize cardiovascular preventive strategies for this group of patients.

  • A Study to Collect and Correlate the Data from Multiple Risk Assessments for Heart Toxicity in Patients Receiving Chemotherapy for Breast Cancer Rochester, MN

    The purpose of this study is to collect and correlate the data from various cardiovascular risk asessments to successfully measure the risk of heart toxicity in patients receiving chemotherapy for breast cancer.

  • A Study to Evaluate the Safety and Effectiveness of Beating Heart Mitral Valve Repair with the HARPOON™ System Rochester, MN

    The purpose of this study is to evaluate the safety and effectiveness of the HARPOON System in the treatment of patients with severe degenerative mitral regurgitation.

  • Identification of Non-gal, Non-HLA Antigens in Patients Implanted with Xenogenic Material Rochester, MN; Scottsdale/Phoenix, AZ; Jacksonville, FL

    The purpose of this study is to identify non-HLA and non-gal protein antigens in transplanted xenogenic tissues (ie bovine or porcine pericardial heart valves) that can then be used to preemptively identify and overcome graft-specific immune responses.

  • Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-term Rochester, MN

    ADAPTABLE is a pragmatic clinical trial in which 20,000 patients who are at high risk for ischemic events will be randomly assigned in a 1:1 ratio to receive an aspirin dose of 81 mg/day vs. 325 mg/day. Study participants will be enrolled over 24 months. Maximum follow-up will be 30 months. The purpose of the study is to identify the optimal dose of aspirin for secondary prevention in patients with Atherosclerotic cardiovascular disease (ASCVD). The primary endpoint is a composite of all-cause death, hospitalization for MI, or hospitalization for stroke. The primary safety endpoint is hospitalization for major bleeding with ...

  • New Technologies to Determine Carotid Plaque Vulnerability Rochester, MN

    Hypothesis: Identification of vulnerable atherosclerotic plaques (with or without neovascularization) using carotid CEUS is an independent predictor of MACE (over clinical risk factors, stress echo wall motion results, and carotid ultrasound two-dimensional speckle tracking strain indices).

    Primary Aims:

    1. Evaluate the diagnostic role of carotid CEUS and two-dimensional speckle tracking strain imaging for detection of carotid plaque:

      • To determine the feasibility and safety of Carotid CEUS and Two-dimensional speckle tracking strain imaging SE .
      • To determine if carotid CEUS and two-dimensional speckle tracking strain imaging findings are associated ...

  • A Study of Shared Decision Making in the Cardiovascular Care of Cancer Patients Seen in the Cardio-oncology Clinic Rochester, MN

    The purpose of this study is to explore, through surveys of providers and patients, the frequency and nature of shared decision making aspects in the cardiovascular care of cancer patients seen in the cardio-oncology clinic referred by an oncology provider.

  • CMRI in CHD Rochester, MN

    The purpose of this study is to create a standardized cardiac MRI imaging protocol for patients with Congenital Heart Disease. 

  • Assessment of Wall Thickness in Hypertrophic Cardiomyopathy Rochester, MN

    Assessment of wall thickness in hypertrophic cardiomyopathy (HCM) is of diagnostic and prognostic importance given its known association with sudden cardiac death. However, data regarding comparison of imaging modalities for this key measurement is lacking. This study seeks to compare assessment of maximum wall thickness between clinically indicated echocardiography (with and without contrast) and clinically indicated cardiac magnetic resonance imaging.

  • A Study to See if MPI SPECT Phase Analysis Can Detect Varying Levels of Changes in Heart Rhythm Patterns Rochester, MN

    The purpose of this study is to determine if MPI SPECT phase analysis can detect varying degrees of abnormal heart rhythm between patients with normal coronary artery circulation, ischemia (poor blood circulation), and infarct (area of dead tissue) from loss of circulation.

  • A Study Evaluating the Effects of Ataciguat (HMR1766) on Aortic Valve Calcification Rochester, MN

    The primary objective of the current study is to determine whether Ataciguat (HMR1766) slows progression of valve calcification in patients with moderate calcific aortic valve stenosis. Secondary and tertiary objectives are to determine whether Ataciguat slows progression of aortic valve function, reduces systemic inflammation, and prevents left ventricular dysfunction in patients with moderate calcific aortic valve stenosis.

  • A Study of the Effect of Dapagliflozin on Symptoms and Biomarkers in Diabetes Patients with Heart Failure Rochester, MN

    The primary purpose of this study is to evaluate the impact of dapagliflozin, as compared with placebo, on heart failure disease-specific biomarkers, symptoms, health status, and quality of life in patients who have type 2 diabetes and chronic heart failure with reduced systolic function.

  • A Feasibility Registry of Actigraphy Monitoring in Degenerative Mitral Regurgitation Subjects Receiving the MitraClip® Device Rochester, MN

    A prospective, open-label, and multi-centered feasibility registry.

  • Usefulness of Computed Tomography in Aortic Stenosis Rochester, MN

    Aims, purpose, or objectives: Evaluate the use and interest of computed tomography as a new tool in Aortic Stenosis evaluation and risk stratification. The objective is to evaluate the impact of new computed tomography indices (global calcification, localized calcification, anatomic measurements…) in aortic stenosis management.

  • 3D Echocardiography Volumetric Measurements in Patients with or without Valvular Heart Disease Rochester, MN

    The purpose of this study is to determine if 3D volumetric measurements will allow more robust quantification of valvular heart disease severity.

  • Assessment of Advanced Magnetic Resonance Imaging in Heart Rochester, MN

    The purpose of this study is to continue the evaluation of non-FDA approved MR equipment software and hardware for imaging the heart and associated vasculature.

  • Invasive Hemodynamic Response in Low Flow versus Normal Flow Aortic Stenosis after Transcatheter Aortic Valve Replacement Rochester, MN

    The purpose of this study is to compare the hemodynamic effects of Low Flow versus Normal Flow Aortic Stenosis after Transcatheter Aortic Valve Replacement.

  • ALLIANCE: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve Rochester, MN

    The purpose of this study is to establish the safety and effectiveness of the Edwards SAPIEN X4 Transcatheter Heart Valve (THV) in subjects with symptomatic, severe, calcific aortic stenosis (AS).

  • SMall Annuli Randomized To Evolut™ or SAPIEN™ Trial Rochester, MN

    The purpose of this trial is to generate clinical evidence on valve safety and performance of self-expanding (SE) versus balloon-expandable (BE) transcatheter aortic valve replacement (TAVR) in subjects with a small aortic annulus and symptomatic severe native aortic stenosis.

  • Cardiac Vascular Reconstruction DynaCT for TAVI Procedures Rochester, MN

    The purpose of this work is to evaluate the feasibility of a new Cardiac Vascular Reconstruction (CAVAREC, Siemens Medical Systems, Germany) image reconstruction algorithm for use during transcatheter aortic valve implant (TAVI) procedures. CAVAREC utilizes the same x-ray projection images as currently acquired for clinical DynaCT. X-ray image acquisition to allow CAVAREC will occur during the TAVI procedure both before and after the TAVI device is implanted. The CAVAREC image processing algorithm will be implemented on an off-line workstation after the TAVI procedure is complete. After the TAVI procedure, CAVAREC images will be quantitatively and qualitatively compared to Siemens DynaCT ...

  • Transfemoral Replacement of Aortic Valve With HLT MeriDIAN Valve Early Feasibility Trial Rochester, MN

    The purpose of this study is to evaluate the safety and performance of the HLT System in patients with severe aortic stenosis who present at High Risk for aortic valve replacement surgery.

  • Transcatheter Aortic Valve Replacement to UNload the Left Ventricle in Patients With ADvanced Heart Failure (TAVR UNLOAD) Rochester, MN

    The objective of this study is to determine the safety and efficacy of transcatheter aortic valve replacement (TAVR) via a transfemoral approach in HF patients with moderate AS as compared with OHFT.

  • New-onset Atrial Fibrillation and Flutter Following Cardiac Surgery Rochester, MN

    The aims of this investigation are:

    To assess the predictive value (and accuracy) of clinical and physiologic preoperative variables in identifying patients at risk for the development of new-onset atrial arrhythmia after cardiac surgery.

    To assess the feasibility of a physiological risk model based on clinical and echocardiographic indexes to predict post-operative AF.

    To assess the role of prophylactic agents in the prevention of new-onset postoperative POAF

    To assess the economic impact of new-onset postoperative AF:

    • Length of hospital stay (will be measured as fractions of days)

    • Hospital cost (will be measured in standardized dollars)

    • Resource utilization (will be measured by resource-based relative-value units)

    To assess the outcome ...

  • Hypertrophic Cardiomyopathy Candidate Gene Homologs in Human and Rhesus Macaque Sudden Cardiac Death Victims Scottsdale/Phoenix, AZ

    The aim of this study is to identify genes shared between humans and rhesus macaque primates who have been diagnosed with hypertrophic cardiomyopathy and have died suddenly.

  • Characterizing Chemo-Radiotherapy Treatment-Related Cardiac Changes Scottsdale/Phoenix, AZ

    The purpose of this study is to determine the 12-month cardiac event rate  after radiation or chemo-radiation for the treatment of lung or esophageal cancer.

  • A Study of Long Term Outcomes of Patients who have had Open Valvotomy for Congenital Aortic Valve Stenosis Rochester, MN

    The purpose of this study is to evaluate the outcomes of surgical Aortic Valvotomy for congenital aortic stenosis.

  • Hypoplastic Left Heart Syndrome: Validating Functional Parameters and Novel Echocardiographic Imaging Strategies for Evaluation of Functionally Single Right Ventricular Performance using Previously Recorded Studies Rochester, MN

    The purpose of this study is to validate novel echocardiographic parameters and algorithms to quantitatively evaluate right ventricular function in patients with Hypoplastic Left Heart Syndrome (HLHS) by applying these methods to previously acquired echocardiographic examinations. 

  • Prospective Identification of Long QT Syndrome in Fetal Life Rochester, MN

    The postnatal diagnosis of Long QT Syndrome (LQTS) is suggested by a prolonged QT interval on 12 lead electrocardiogram (ECG),a positive family history and/or characteristic arrhythmias and confirmed by genetic testing.  LQTS testing cannot be performed successfully before birth as   fetal ECG is not possible and direct measure of the fetal QT interval by magnetocardiography is limited. Genetic testing can be performed in utero, but there is risk to the pregnancy and the fetus. Although some fetuses present with arrhythmias easily recognized as LQTS (torsade des pointes (TdP) and/or 2° atrioventricular (AV) block, this is uncommon, occurring in <25% of fetal ...

  • A Study to Evaluate Brain Natriuretic Peptides for the Avoidance of Treatment-Related Heart Failure in Breast Cancer Survivors Rochester, MN

    The purpose of this study is to determine if Brain Natriuretic Peptide (NT-pro-BNP) values increase over time in breast cancer survivors and correlate with cardiac dysfunction. This study will define the average NT-pro-B-natriuretic peptide values in female breast cancer patients 1, 2, 3, 4, and 5 years out from anthracycline-based chemotherapy.

  • A Study to Evaluate Potential Myocardial Injury Following Elective Direct Current Cardioversion Rochester, MN

    The purpose of this study is to prospectively determine if direct current cardioversion (DCCV) results in myocardial injury as assessed by changes in high sensitivity cardiac troponin T (hs-cTnT) assay.

  • TVMR With the Innovalve System Trial - Early Feasibility Study Rochester, MN

    The purpose of this study is to assess the technical and procedural success of the Innovalve TMVR system when used to treat adult patients with symptomatic moderate-severe and severe mitral regurgitation who are at elevated risk for surgical mitral valve repair or replacement and who are anatomically eligible for a transfemoral catheterization with transseptal approach to the left atrium.

     

     

  • The PARTNER 3 - AVIV Trial Rochester, MN

    To assess the safety and effectiveness of the SAPIEN 3/SAPIEN 3 Ultra (Edwards Lifesciences, Irvine, California) transcatheter heart valve in patients with a failing aortic bioprosthetic valve.

  • Staging Classification of Severe Tricuspid Regurgitation Using Novel Cardiac Imaging Techniques Rochester, MN

    The purpose of this study is to assess the severity of tricuspid regurgitation (a disorder in which the tricuspid valve in your heart does not close tight enough) using cardiac magnetic resonance imaging (MRI).

  • Evaluation of Transcatheter Aortic Valve Replacement Compared to SurveilLance for Patients With AsYmptomatic Severe Aortic Stenosis Rochester, MN

    This clinical trial is a prospective, randomized, controlled, multi-center study. Patients will be randomized 1:1 to receive either transcatheter aortic valve replacement (TAVR) with the Edwards SAPIEN 3 THV or clinical surveillance. Patients will be stratified by whether or not they are able to perform a treadmill stress test. Patients who have a positive stress test will be followed in a registry to collect data on subsequent treatment and mortality, as applicable.

  • Left Ventricular Ejection Hemodynamics in Patients with Hypertrophic Cardiomyopathy and Valvular Aortic Stenosis Rochester, MN

    The purpose of this study is to compare ejection hemodynamics in patients with obstructive hypertrophic cardiomyopathy (HCM) before and after septal myectomy.

  • A Study to Evaluate a Computerized Stethoscope called ©CompuSteth to Diagnose Heart Disease Rochester, MN

    The purpose of this study is to identify patients presenting to the echocardiogram laboratroy for routine clinically indicated echocardiography or to the cardiac catheterization laboratory for routine clinically indicated catheterization procedures. These patients will undergo a cardiac physical examination using the ( VoqX) stethoscope for the following 2 aims:

    1) Collect computerized auscultation data to train the ©VoqX device on how a variety of cardiac pathologies "sound", including normal heart sounds, aortic stenosis, and mitral valve disease, after identifying these cardiac pathologies using gold-standard testing with echocardiography or invasive cardiac catheterization.

    2)Prospectively determine the accuracy of the ©VoqX device as a tool to non-invasively screen for ...

  • A Study of Information Provided by Cardiopulmonary Exercise Testing When Evaluating Patients with Aortic Stenosis Rochester, MN

    The purpose of this study is to find if cardiopulmonary exercise testing data will provide any predictive information in evaluating patients with aortic stenosis for severity, symptoms and surgical risk.

  • An Evolut™ EXPAND TAVR II Pivotal Trial Rochester, MN

    The purpose of this study is to obtain safety and effectiveness data to support indication expansion for the Medtronic transcatheter aortic valve replacement (TAVR) System to include patients with moderate, symptomatic Aortic Stenosis (AS).

  • A Study to Compare Conventional Heart Echo Measurements with Newer 2 and 3 Dimensional Measurements of Mechanical Heart Strain after Trastuzumab Infusion Rochester, MN

    The purpose of this study is to compare conventional assessment of systolic ventricular function on a 2D heart echo with an assessment of more immediate changes in heart mechanics using 2D and 3D measurements of deformation and strain in patients undergoing infusion of Trastuzumab for breast cancer.

  • A Study of the Impact of Frailty on Health Outcomes following Aortic Valve Replacement Rochester, MN

    The purpose of this study is to determine what factors predict poor surgical outcomes, and the extent to which patient-centered outcomes differ between participants deemed frail and non-frail.

  • Invasive Hemodynamic Response to Transcatheter Edge-to-Edge Mitral Valve Repair Rochester, MN

    We hypothesize that (1) Patients with significant left atrial pressure (LAP) reduction during transcatheter mitral valve repair (TMVR) have lower cardiac output, more advanced diastolic dysfunction, increased left atrial stiffness, abnormal pulmonary vascular function and higher arterial afterload compared to TMVR patients without a significant LAP reduction. (2) TMVR and associated reduction in mitral regurgitation and LAP results in relief of pulmonary vascular congestion, and improvement in pulmonary vascular and right ventricular function.

  • Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Severe, Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement (SURTAVI). Rochester, MN

    The purpose of the study is to investigate the safety and efficacy of transcatheter aortic valve implantation (TAVI) in patients with severe, symptomatic Aortic Stenosis (AS) at intermediate surgical risk by randomizing patients to either Surgical Aortic Valve Replacement (SAVR) or TAVI with the Medtronic CoreValve® System. Single Arm: The purpose of this trial is to evaluate the safety and effectiveness of transcatheter aortic valve implementation (TAVI) in patients with sever symptomatic Aortic Stenosis (AS) at intermediate surgical risk with TAVI. This is a non-randomized phase of the pivotal clinical trial.

  • Vascular Diseases Biorepository Rochester, MN

    The eventual goal of this study is to identify genetic and proteomic markers that may influence susceptibility to vascular diseases including peripheral arterial disease, pulmonary hypertension, carotid artery stenosis, arterial aneurysmal disease, fibromuscular dysplasia, congenital heart disease and other less common diseases that affect the blood vessels.

  • Function of Artificial Intelligence-enabled Electrocardiogram in Early Detection of Patients With Aortic Stenosis Rochester, MN

    The purpose of this study is to determine the performance of AI-ECG as a screening tool in clinical practice identifying patients with moderate or severe AS, to determine the ability of POCUS in detecting moderate or severe AS amongst in patients with positive AI-ECG.

    Additionally, to identify which clinical features (presence of cardiac murmur, prevalence of hypertension, age or sex) can improve decision making process of applying echocardiography exam in patients with positive AI-ECG.

  • Clinical and Imaging Factors Associated with Symptoms in Patients with Severe Aortic Stenosis Rochester, MN

    The aim of this study is to reveal differences between symptomatic and asymptomatic severe AS patients matched for anatomic (aortic valve area) and hemodynamic (mean gradient) AS severity. The secondary aim is to evaluate functional and prognostic significance of strain value of LV and RV.

  • "About Me" Pedigree Tool Pilot Rochester, MN

    The objective of this study is to determine the utility and accuracy of patients utilizing the About Me pedigree tool to create their own pedigrees for use in risk assessment in a cardiovascular genetics clinic. 

  • A Study Comparing Apixaban to Vitamin K Antagonist for the Prevention of Stroke or Systemic Embolism and Bleeding in Patients with Non-valve Atrial Fibrillation and Acute Coronary Syndrome or Percutaneous Coronary Intervention Scottsdale/Phoenix, AZ

    The purpose of this study is to determine if apixaban given for 6 months is safer than Vitamin K Antagonist (VKA) given for 6 months in terms of major bleeding and non-major bleeding in patients with an irregular heart beat (atrial fibrillation) and a recent heart attack or in atrial fibrillation patients undergoing a procedure to open up a blood vessel in the heart (percutaneous coronary intervention). All patients would also be taking a class of medicines called P2Y12 inhibitors (such as clopidogrel). All patients would be treated for an intended 6 months.

  • A Repository of Atria Tissue for the Investigation of Atrial Pathophysiology in Patients with Atrial Fibrillation Rochester, MN

    The purpose of this study is to collect surgically removed atrial tissue for genetic, pathologic, metabolic, and molecular studies in patients with or without a history of atrial fibrillation.

  • A Study to Evaluate the Effectiveness and Safety of DA-1229 (Evogliptin) in Delaying Progression of Mild or Moderate Calcific Aortic Stenosis (EVOID-AS trial) Jacksonville, FL; Rochester, MN; Scottsdale/Phoenix, AZ

    The purpose of this study is to evaluate the effectiveness and safety of DA-1229 compared to placebo in patients with calcific aortic valve disease with mild to moderate aortic stenosis. There are 3 arms in this study to which patients will be randomized in a ratio of 1:1:1 to receive the DA-1229 or placebo orally once daily for a period of 104 weeks. The 3 arms are: placebo, DA-1229 5mg Group, and DA-1229 10 mg Group. The study will have three phases: Screening Period (up to 4 weeks), Treatment Period (104 weeks), and Follow-Up Period (2-4 weeks). Total Study Duration is ...

  • Collection of Blood and Tissue in Patients with Aortic Stenosis Scottsdale/Phoenix, AZ

    The goal of this study is to create a comprehensive system of blood and tissue banking of samples from Mayo Clinic Arizona patients with a clinical diagnosis of aortic stenosis who are either undergoing routine care at Mayo Clinic or undergoing aortic valve surgery.  The tissue samples will be used for future research of aortic stenosis at Mayo Clinic and future research at Mayo Clinic to learn about, prevent, or treat other health problems.

  • Mild to Moderate Calcified Aortic Stenosis Registry Rochester, MN

    The purpose of this study is to identify and follow a population of mild to moderate aortic stenosis patient to assess the natural history of aortic stenosis in the 2010’s. 

  • Left Ventricular Remodeling Post-TAVR Rochester, MN

    There has been a paradoxical finding in clinical trials with severe AS patients that LV mass regression is greater and faster after surgical AVR compared to transcatheter AVR while hemodynamic profile is better after TAVR compared to SAVR. We do have a preliminary finding to explain this paradox and want to validate it.

  • Comprehensive Imaging and Biomarker Assessment of Aortic Valve Stenosis Rochester, MN

    The purpose of this study is detection of relationship between biomarkers and the severity of AS (echocardiographic hemodynamics/CT-calcium load).  Detection of relationship between biomarkers to the consequences of AS on the LV (echo remodeling parameters and speckle-tracking LV strain).  Detection of differences on echocardiographic and CT-calcium load AS severity assessments between tricuspid and bicuspid valves.  Detection of biomarker associations with AS hemodynamics, CT-calcium load, LV remodeling and LV strain between tricuspid and bicuspid phenotypes. 

  • PROACT Xa - A Trial to Determine if Participants With an On-X Aortic Valve Can be Maintained Safely on Apixaban Rochester, MN

    The purpose of this study is to determine if participants with an On-X Prosthetic Heart Valve / On-X aortic valve can be maintained safely and effectively on apixaban. Both the On-X aortic valve and apixaban have been approved for use by the US Food and Drug Administration (FDA) but they have not been approved to be used together.  Currently, warfarin is the only approved anticoagulation for patients with mechanical valves.

  • Early Feasibility Study of the Edwards FORMA Tricuspid Transcatheter Repair System Rochester, MN

    The study is a multi-center, prospective, early feasibility study to measure individual patient clinical outcomes and effectiveness, evaluate the safety and function, provide guidance for future clinical study designs and development efforts of the Edwards FORMA Tricuspid Transcatheter Repair System.

  • Usefulness of Color M-mode for Vena Contracta of Aortic Regurgitation in Patients with Left Ventricular Assist Devices Rochester, MN

    The purpose of this study is to assess the feasibility of color M mode and standard vena contracta measurements and compare these to novel measurements of aortic regurgitation in left ventricular assist devices (LVADs).

  • Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation Rochester, MN

    The purpose of this study is to evaluate the safety and effectiveness of the Tendyne™ Mitral Valve System for the treatment of patients with symptomatic, moderate-to-severe or severe mitral regurgitation or for patients with symptomatic mitral valve disease due to severe mitral annular calcification.

  • Multicenter Prospective Study of Low-Flow Low-Gradient Aortic Stenosis (TOPAS Study) Rochester, MN

    Low-flow, low-gradient (LF-LG) aortic stenosis (AS) may occur with depressed (i.e. Classical LF; CLF) or preserved (i.e. Paradoxical LF; PLF) LV ejection fraction (LVEF) and both situations are amongst the most challenging encountered in patients with valvular heart disease. Although, CLF-LG AS is recognized has an important clinical entity, current ACC/AHA-ESC guidelines however do not provide precise recommendations for clinical management of these patients . PLF-LG AS is a new entity recently described by our group, which is characterized by more pronounced LV concentric remodeling with smaller LV cavity size and a restrictive physiology leading to impaired LV filling, altered ...

  • Aortic Valve Operative Outcomes in Marfan Patients Rochester, MN

    The purpose of this study is to evaluate and compare operative outcomes of the aortic valve-sparing (AVS) and aortic valve replacement (AVR) surgical interventions in different categories of patients with Marfan syndrome and estimate the predictors of the surgical outcomes.

  • A Study to Analyze Rhythm Control and Potential Early Surgery for Tricuspid Regurgitation Rochester, MN

    The purpose of this study is to determine the efficacy of a strategy of rhythm control to treat severe TR due to AF, followed by early surgery in non-responders to rhythm contron and to determine baseline clinical and hemodynamic predictors of symptom benefit following effective TR reduction. 

     

  • Spontaneous Coronary Artery Dissection (SCAD):Utility of Echocardiography including Contrast and Strain Imaging Rochester, MN

    The purpose of this study is to perform and analyze standard transthoracic echocardiography with contrast and strain imaging in 80 consecutive patients seen in the Mayo Clinic Spontaneous Coronary Artery Dissection (SCAD) Clinic and interpret any prior pre- or post-SCAD echocardiogram studies for comparison.

  • A Study of the Effect of Sildenafil for Improvement of Hepatic Fibrosis after the Fontan Heart Surgery Rochester, MN

    The purpose of this study is to determine if vasodilators for the lungs can decrease liver stiffness, shown by Magnetic resonance elastography (MRE).  The study also aims to identify any clinical, laboratory, echocardiographic, imaging, and hemodynamic parameters that connect with improved outcomes of cardiac and liver status after starting the pulmonary vasodilators.

  • Safety of BM-MNC Intramyocardial Delivery in Ebstein RV Rochester, MN

    The objective of this study is to evaluate the safety and feasibility of autologous mononuclear cells (MNC) collected from bone marrow (BM) delivered into the myocardium of the right ventricle of subjects with Ebstein anomaly undergoing surgical Ebstein repair. Additionally, the potential cardiovascular benefits will also be evaluated. This add-on procedure is anticipated to pose little risk to the subject and has the potential to foster a new strategy that leverages the regenerative capacity of individuals with congenital heart disease during the surgically mandated Ebstein repair.

  • Caisson Transcatheter Mitral Valve Replacement (TMVR) System Early Feasibility Study Rochester, MN

    The purpose of this study is to assess the safety and performance of the Caisson Interventional Transcatheter MitralValve Replacement (TMVR) system for the treatment of severe symptomatic MitralValve Regurgitation (MR).

  • Caregiver Monitoring of Children with Congenital Heart Disease Rochester, MN

    The overall objective of this study is to determine whether non-medically trained caregivers can be educated to utilize home monitoring devices paired with our mobile application to collect and store patient-specific information regarding weight, pulse, and oxygen saturation levels for congenital heart disease patients.

  • Inclisiran for Participants With Atherosclerotic Cardiovascular Disease and Elevated Low-density Lipoprotein Cholesterol Rochester, MN

    This is a Phase III, placebo-controlled, double-blind, randomized study in participants with ASCVD and elevated LDL-C despite maximum tolerated dose of LDL-C lowering therapies to evaluate the efficacy, safety, and tolerability of subcutaneous (SC) inclisiran injection(s). The study will be a multicenter study in the United States.

  • A Study of Aortic Valve Gradient Severity in Patients with Atrial Fibrillation Rochester, MN

    The purpose of this study is to examine if the measurements that we make by current standards for patients with both aortic stenosis (narrowed aortic valve) and atrial fibrillation underestimate severity of aortic stenosis and if that has any effect on timing of aortic valve surgery

  • Vascular Function and Uterine Fibroids Rochester, MN

    The purpose of this study is to learn how uterine fibroids may be connected to heart disease and high blood pressure. It is not known what causes fibroids, but they frequently occur in women who also have high blood pressure, heart disease, and stroke. The investigators of this study want to learn if certain changes in the blood vessels or nerve activity can put women at risk for these diseases and for fibroids.

  • Study of Incidence of Respiratory Tract AEs in Patients Treated With Tyvaso® Compared to Other FDA Approved PAH Therapies Jacksonville, FL

    A surveillance of respiratory tract related adverse events in patients treated with Tyvaso® (treprostinil) Inhalation Solution versus other FDA approved therapies.

  • Non-Invasive Assessment of Valvular Regurgitation Rochester, MN

    Measure by Doppler color automated integration cardiac stroke volumes and calculate regurgitant volume.

  • Ventricular Remodeling and Myocardial Deformation in Patients Undergoing Chemotherapy for Sarcomas Rochester, MN

    The aim of this study is to determine if there is subclinical systolic or diastolic myocardial mechanical dysfunction by 2D and 3D speckle tracking echocardiography derived strain and strain rate in this patient population at baseline, during and after chemotherapy. This could be an early marker  of myocardial dysfunction  in patients treated for sarcoma.

  • Physiologic Effects of Sleep Restriction Rochester, MN

    Evidence suggests a relationship between sleep deprivation and cardiovascular disease. The investigators wish to determine whether 9 nights of modest sleep restriction results in activation of cardiovascular disease mechanisms, thus potentially increasing the risk of cardiovascular disease. The investigators hypothesize that sleep restriction will result in elevated blood pressure, inflammation, and neurocognitive deficits.

  • The Effects of Aortic Valve Replacement on Sleep Disordered Breathing, Heart Rate Variability and Ventricular Ectopy Burden in Patients with Severe Aortic Stenosis Rochester, MN

    Our overall goal is to determine whether the AVR improves SDB where present and sleep profiles (including sleepiness symptoms, quality of life and hypoxia).

  • Prevalence of Transthyretin Cardiac Amyloidosis in Clinically Significant Aortic Stenosis Rochester, MN

    The purpose of this study is to determine the prevalence of TTR-CA in a community-based cohort of moderate and severe aortic stenosis patients using 99mTc-PYP single-photon positive emission computed tomography with computed tomography (SPECT/CT).

  • An Evaluation of the MitraClip System for treatment of Mitral Regurgitation in Heart Failure Patients Scottsdale/Phoenix, AZ

    The purpose of the Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation (COAPT) Trial is to confirm the safety and effectiveness of the MitraClip System for the treatment of moderate-to-severe or severe functional mitral regurgitation (FMR) in Symptomatic Heart Failure Subjects who are treated per standard of care and who have been determined by the site's local heart team as not appropriate for mitral valve surgery. This randomized controlled trial will provide the opportunity to strengthen or add labeling claims regarding safety and clinical benefits of the MitraClip System for symptomatic heart ...

  • Evaluating Childhood Cardiovascular Health Outcomes in NEPTUNE and CureGN Rochester, MN

    The purpose of this research study is to learn more about the risks to heart health in children and young adults with nephrotic syndrome. Nephrotic syndrome is a rare kidney condition that can affect children. They may be more likely to develop heart disease, high blood pressure and high cholesterol. We hope that the results of this study will help us to learn which tests should be used to determine which patients are most at risk for developing these illnesses.

  • Early Feasibility Study of the CardioMech Mitral Valve Repair System (MVRS) Rochester, MN

    The purpose of the clinical study is to obtain clinical data on the CardioMech Mitral Valve Repair System (MVRS) in patients diagnosed with moderate to severe (≥ 3+) or severe (≥ 4+), symptomatic, degenerative mitral regurgitation with prolapse or flail of the P2 leaflet segment, and who are determined to be at intermediate or high-risk for mitral valve surgical repair, as assessed by the multi-disciplinary heart team.

  • Mitral Valve Prolapse in the Setting of Previous Open Heart Surgery Rochester, MN

    The purpose of this study is to compare outcomes of MitraClip vs open mitral valve repair in patients with severe mitral regurgitation (MR) due to mitral valve prolapse (MVP) in those who have already undergone a previous open heart surgery.

  • Stress Echo 2030 Rochester, MN

    This study (SE2030) will establish a platform of data to build the perfect stress echo test, suitable for all patients, anywhere, anytime, also quantitative and operator independent.

  • COVID-19 (Coronavirus) Pandemic on Health and Healthcare Rochester, MN

    The purpose of this study is to identify correlates of healthcare-seeking behavior in patients with ACS and CHF and its association with psychosocial and health outcomes.

  • Spontaneous Coronary Artery Dissection: Case Review Rochester, MN

    Spontaneous coronary artery dissection (SCAD) is uncommon but important cause of acute coronary syndrome and sudden cardiac death. There is very little data exists in regards to patient clinical characteristics, risk factors, treatment and outcomes. Our objective is to prospectively assess long term outcomes. 

  • A Study to Evaluate the Safety and Effectiveness of GORE® CARDIOFORM Septal Occluder to Treat Migraine Headaches Scottsdale/Phoenix, AZ

    The purpose of this study is to evaluate Patent Foramen Ovale (PFO) closure for migraine headache relief using the GORE® CARDIOFORM Septal Occluder after a trial of oral anticoagulation therapy vs. placebo for a 6 week period.

  • Cardiotoxic Effects of Chemotherapy in Patients with Sarcomas Rochester, MN

    The purpose of this study is to determine if two-dimensional speckle tracking echocardiography (2D-STE) derived-strain can detect early myocardial dysfunction and thus predict cardiotoxicity in sarcoma subjects undergoing anthracycline therapy and to compare three dimensional speckle tracking echocardiography (3D-STE) to 2D-STE in the same group of patients.

  • Exercise during Heart Cath in CHD Patients Rochester, MN

    The purpose of this study is to compare the difference in the ability to detect blood flow abnormalities between invasive assessments performed at rest versus exercise.

  • COVFIS-HOME: COVID-19 Pilot Study of Fisetin to Alleviate Dysfunction and Decrease Complications Rochester, MN

    The purpose of this study is to determine whether short-term treatment with Fisetin reduces the rate of death and long term complications related to COVID-19.

  • Using Ultrasonography, Shear Wave Elastography, Strain Imaging, and 3-D Volume Ultrasonography on Cardiovascular Disease Rochester, MN

    The researchers are trying to see whether contrast-enhanced ultrasonography, shear wave elastography, strain imaging, and 3-D volume ultrasonography improves arterial wall visualization and identifies arterial elastic properties among individuals with fibromuscular dysplasia (FMD), atherosclerosis, personal history of spontaneous coronary artery dissections (SCAD), or personal history of segmental arterial mediolysis (SAM) that may be different compared to those without the aforementioned conditions.

  • Evaluating the Benefit of Concurrent Tricuspid Valve Repair During Mitral Surgery Rochester, MN

    The purpose of the research is to determine whether repairing a tricuspid valve (TV) in patients with mild to moderate tricuspid regurgitation (TR), at the time of planned mitral valve surgery (MVS), would improve the heart health of those who receive it compared to those who do not. At this point, the medical community is split in their opinion on whether surgeons should routinely repair mild to moderate TR in patients who are undergoing planned mitral valve surgery, and this study will answer this question.

  • A Study of Strain Echocardiography in Assessment of Valvular Heart Disease Rochester, MN

    Classical echocardiographic assessment of heart valves is critical in determination of disease severity. However, echocardiography has only limited ability to predict how well an individual patient will do at time of surgery. New echocardiographic technology allows us to measure new, more refined parameters of your heart’s performance. This study is investigating whether these new parameters are better in predicting outcomes.

  • A Study to Evaluate the Effectiveness and Safety of Remdesivir to Treat Coronavirus Disease 2019 in an Outpatient Setting Rochester, MN

    The purpose of this study is to evaluate the effietiveness of remdesivir (RDV) in reducing the rate of of all-cause medically attended visits (MAVs; medical visits attended in person by the participant and a health care professional) or death in non-hospitalized participants with early stage coronavirus disease 2019 (COVID-19) and to evaluate the safety of RDV administered in an outpatient setting.

  • A Study to Evaluate Aortic Dilatation in Patients with Conotruncal Abnormalities Rochester, MN

    The purpose of this study is to assess operative and postoperative outcomes after aortic valve surgery, evaluate for changes in ascending aorta diameter by comparing pre-operative CT imaging to measurements on follow-up imaging, and examine late outcomes and functional status during the follow-up period with specific focus on mortality, need for re-operation and incidence of aortic dissection.

  • A Study to Assess the Role of Biomarkers in Risk Stratification in Adults with Congenital Heart Disease Rochester, MN

    The purporse of this study is to determine if biomarker assay obtained at baseline can predict future risk of cardiovascular adverse events, and to  determine if temporal changes in biomarker levels can provide a better risk prediction compared to biomarker assay obtained at baseline.

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