Clinical Trials

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.

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.

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.

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.

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 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.

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.

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.

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.

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.

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.

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.

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

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.

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.

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.

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).

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.

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.

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

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).

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.

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 ...

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.

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.

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).

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

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).

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.

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 ...

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. 

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.

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.

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.

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 ...

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.

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. 

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. 

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.

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

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.

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.

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.

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

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 ...

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.

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

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.

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.

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

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.

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.

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).

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.

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

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).

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 ...

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.

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.

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.

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.

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.

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.

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.

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.