Clinical Trials

Prospective, randomized, parallel-controlled, multicenter clinical evaluation of the Evolut-R catheter based aortic valve for the treatment of clinically significant aortic stenosis in low surgical risk subjects.

Prospective, randomized, parallel-controlled, multicenter clinical evaluation of the presence or absence of acquired von Willebrand syndrome in patients undergoing implantation with Heartmate II or Heartmate III LVADs.

The major goal of this project was to isolate, characterize and genetically modify mesenchymal stem cells isolated from adult animals, and demonstrate that they participate in cardiac repair, induce functional recovery, and reverse ventricular remodeling.

Implantation of left ventricular assist devices can perturb the normal homeostatic mechanisms that regulate clotting and bleeding because of shear stresses and exposure of the bloodstream to foreign surfaces. This randomized clinical trial investigates the role of a novel intrinsic pathway antagonist in achieving balance between the bleeding and clotting cascades in patients undergoing LVAD implantation.

This randomized controlled trial aims to see if patients undergoing injection of allogeneic mesenchymal stem cells at the time of LVAD implantation can recover myocardial function to the point of undergoing LVAD explantation, and no longer require heart transplantation.

Bronchial anastomotic complications affect around 15% of lung transplant recipients adding considerable morbidity and early mortality to recipients of lung transplantation. Direct revascularization of the bronchial arteries using the internal mammary artery at time of transplantation promises to decrease airway ischemic complications and may decrease the incidence of bronchiolitis obliterans syndrome.

The study is designed to characterize the safety and effectiveness of the DuraHeartTM LVAS in bridge to transplantation patients. The study’s primary endpoints are survival to cardiac transplantation or survival to180 days on the device while remaining transplant listed UNOS status 1A or 1B, survival to explant for myocardial recovery with the patient surviving to 60 days after device removal or hospital discharge, whichever is longer, without requirement for subsequent mechanical support (such as LVAS, IABP, extracorporeal membrane oxygenation)

The purpose of this trial is to evaluate the safety and efficacy of surgical ablation versus no surgical ablation for patients with persistent or longstanding persisntent atrial fibrillation undergoing mitral valve operation.

The purpose of this trial is to evaluate the safety and efficacy of mitral valve repair versus no mitral valve repair for patients with moderate mitral regurgitation in the setting of ischemic heart disease undergoing surgical coronary revascularization.

The purpose of this investigation is to evaluate the safety and effectiveness of the CentriMag VAS when used in failure-to-wean from cardiopulmonary bypass1 patients until the patient can be weaned and: a) no longer requires mechanical circulatory support, b) undergoes heart transplantation or c) undergoes further treatment with a commercially available long-term heart assist system.

Risk Assessment and Comparative Effectiveness Of Left Ventricular Assist Device and Medical Management in Ambulatory Heart Failure Patients. Evaluate and compare the effectiveness of HM II LVAD support versus OMM in ambulatory NYHA Class IIIB/IV HF patients who are not dependent on intravenous inotropic support and who meet the FDA approved indications for HM II LVAD destination therapy.

The purpose of this observational registry is to determine the freedom from DL infection events in subjects implanted with a HeartMate II LVAD in whom only the silicone portion of the DL is externalized resulting in a silicone skin interface (SSI).

Prevention of cardiac allograft vasculopathy using Rituximab therapy in cardiac transplantation. To determine the cumulative impact of rituximab on the development of coronary allograft vasculopathy in heart transplant recipients in the first-year post transplant. Using intravascular ultrasound, a volumetric measure of CAV will be obtained and quantified by a core lab to compare CAV development in patients treated with rituximab and placebo.

A prospective, randomized, multicenter, parallel-arm study evaluating the overall efficacy and safety of desensitization therapy on selected patients awaiting heart transplantation. The purpose of this research study is to find out if the drug Bortezomib (VELCADE ®), along with a procedure called plasmapheresis, can be effective at desensitization. We will be testing whether this treatment lowers antibody levels, and whether as a result patients have fewer complications while waiting for their transplant.

Prospective, randomized, parallel-controlled, multicenter clinical evaluation of the CoreValve catheter based aortic valve for the treatment of clinically significant aortic stenosis in extreme high surgical risk subjects.

Prospective, randomized, parallel-controlled, multicenter clinical evaluation of the CoreValve catheter based aortic valve for the treatment of clinically significant aortic stenosis in extreme high surgical risk subjects.

Prospective, randomized, parallel-controlled, multicenter clinical evaluation of the Portico re-sheathable catheter based aortic valve for the treatment of clinically significant aortic stenosis in extreme high surgical risk subjects.

Prospective, randomized, parallel-controlled, multicenter clinical evaluation of the Evolut-R catheter based aortic valve for the treatment of clinically significant aortic stenosis in extreme high surgical risk subjects.

Prospective, randomized, parallel-controlled, multicenter clinical evaluation of the GLX treatment system for the treatment of clinically significant aortic stenosis in surgical subjects.

INTERMACS® is a national registry for patients who are receiving mechanical circulatory support device therapy to treat advanced heart failure. This registry was devised as a joint effort of the National Heart, Lung and Blood Institute (NHLBI), the Centers for Medicare and Medicaid Services (CMS), the Food and Drug Administration (FDA), clinicians, scientists and industry representatives. The PI is responsible for oversight of data submissions and registry compliance.

Prospective, randomized, parallel-controlled, multicenter clinical evaluation of the MitraClip device for the treatment of clinically significant functional mitral regurgitation in extreme high surgical risk subjects.

Prospective, randomized, parallel-controlled, multicenter clinical evaluation of the 34-mm Evolut-R catheter based aortic valve for the treatment of clinically significant aortic stenosis in extreme high surgical risk subjects.

Prospective, randomized, parallel-controlled, multicenter clinical evaluation of the Evolut-R 2.0 catheter based aortic valve for the treatment of clinically significant aortic stenosis in extreme high surgical risk subjects.

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.

The study is designed to characterize the safety and effectiveness of the Heartmate-3 LVAD in bridge to transplantation patients. The study’s primary endpoints are survival to cardiac transplantation or survival to 180 days on the device while remaining transplant listed UNOS status 1A or 1B, survival to explant for myocardial recovery with the patient surviving to 60 days after device removal or hospital discharge, whichever is longer, without requirement for subsequent mechanical support (such as LVAD, IABP, extracorporeal membrane oxygenation)

MOMENTUM3 CAP multicenter study of MagLev Technology in patients undergoing MCS Therapy with HeartMate 3 continued access protocol.