-
In Situ Measurement of Anti-Apoptotic Phenotype in the Pulmonary Arterial Endothelium and Its Association with Pre-Capillary Disease in Pulmonary Hypertension
Rochester, MN
The purpose of this study is to collect pulmonary arterial endothelial cells from the balloon tips of pulmonary artery catheters (PAC) during right heart catheterization (RHC) and to measure bcl-2 protein expression in these cells in order to index this measurement to a composite hemodynamic and clinical indicators of precapillary vascular disease in pulmonary hypertension.
-
ISCHEMIA-Chronic Kidney Disease Trial
Rochester, MN
The purpose of the ISCHEMIA-CKD trial is to determine the best management strategy for patients with stable ischemic heart disease (SIHD), at least moderate ischemia and advanced chronic kidney disease (CKD; estimated glomerular filtration rate [eGFR] <30 or on dialysis). This is a multicenter randomized controlled trial with a target randomization of ~1000 patients with advanced CKD and at least moderate ischemia on stress testing. Participants 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 ...
-
Fontan Extra-Cardiac Conduit Stenosis and Stent Placement
Rochester, MN
The purpose of the study is to determine if extra cardiac conduit stenosis was found in Fontan patients who previously had a cardiac catheterization at Mayo Clinic and if subsequently treated with conduit stent placement in order to determine if stenting is effective in relief of clinical symptoms.
-
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 ...
-
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 of the Use of the Hansen Medical System in Patients with Paroxysmal Atrial Fibrillation
No Locations
The purpose of this study is to assess the safety and performance of the Hansen Medical Sensei Robotic System and Artisan Catheter when used to robotically manipulate RF ablation catheters for the treatment of paroxysmal atrial fibrillation (irregular heartbeats originating in the upper chambers of the heart).
-
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.
-
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 Using a Combined Lung and Heart Point of care ultrasound (POCUS) Examination to Estimate Cardiac Filling Pressures in Hospitalized Patients
Rochester, MN
The purpose of this study is to implement a rapid hemodynamic heart-lung protocol performed at the bedside by cardiology and critical care fellows and subsequently correlate ultrasound-derived hemodynamic parameters with PAC-derived parameters.
-
A Study to Evaluate Echocardiographic Doppler and Invasively-Measured Hemodynamics for Cardiac Catherization Referral Patients
Rochester, MN
This study is being done to evaluate correlations between echocardiographic Doppler parameters and invasively-measured hemodynamics both at rest and during exercise in a broad cohort of patients referred for cardiac catheterization.
-
Rivaroxaban Post-Transradial Access for the Prevention of Radial Artery Occlusion
Rochester, MN
The purpose of this study is to answer the question: “Does a short course of oral anticoagulation with a direct oral anticoagulant after transradial access for coronary angiography/left heart catheterization and/or percutaneous coronary intervention reduce the incidence of radial artery occlusion?” The hypothesis is that oral anticoagulation will reduce the incidence of radial artery occlusion at 30 days without a significant increase in the rate of clinically significant bleeding.
-
Extent and Severity of Intravascular Volume Overload in Relation to Right Heart Catheter Hemodynamic Parameters
Rochester, MN
The purpose of this study is to assess the extent and severity of plasma volume expansion and overload in patients requiring ultrafiltration/dialysis and determine the relationship of quantitated Blood Volume Analysis (BVA) to hemodynamic right heart measurements.
-
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.
-
Invasive and Noninvasive Assessments of Myocardial Elasticity
Rochester, MN
The purpose of this study is to assess the correlation between myocardial elasticity (ME) measurements obtained simultaneously during cardiac hemodynamic catheterization and intraprocedural echocardiography.
-
Review of the Safety and Effectiveness of the THERMOCOOL SMARTTOUCH® SF Catheter Evaluated for Treating Symptomatic PersistenT AF (PRECEPT)
No Locations
This is a prospective, multicenter, non-randomized clinical evaluation utilizing the THERMOCOOL SMARTTOUCH® SF catheter compared to a predetermined performance goal.
-
nMARQ™ Pulmonary Vein Isolation System for the Treatment of Paroxysmal Atrial Fibrillation
No Locations
To demonstrate safety and effectiveness of nMARQ Catheter System [nMARQ] compared with THERMOCOOL® Navigational Family of catheters in treating subjects with drug-refractory symptomatic paroxysmal atrial fibrillation (PAF).
-
A Study to Compare the Effectiveness of Invasive versus Conservative Medical Approaches in Patients with Stable Ischemic Heart Disease and Advanced Chronic Kidney Disease
Scottsdale/Phoenix, AZ
The purpose of the ISCHEMIA-CKD trial is to determine the best management strategy for patients with stable ischemic heart disease (SIHD), at least moderate ischemia and advanced chronic kidney disease (CKD; estimated glomerular filtration rate [eGFR] <30 or on dialysis). This is a multicenter randomized controlled trial with a target randomization of ~1000 patients with advanced CKD and at least moderate ischemia on stress testing. Participants 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 ...
-
A Study of Transthoracic Echocardographic Assessment for Pulmonary Artery Pressure Measurements
No Locations
The purpose of this study is to improve the noninvasive assessment of right atrial pressures by correlating tradiational echo findings with other echo indicators using the gold standard of right heart catheterization as the correlation.