Heart Valve Disease Clinical Trials | NYU Langone Health

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Division of Adult Cardiac Surgery Heart Valve Disease Clinical Trials

Heart Valve Disease Clinical Trials

Physicians and researchers in NYU Langone’s Division of Adult Cardiac Surgery conduct clinical trials to explore new, more effective treatments for people who have heart valve conditions requiring surgical intervention.

We are actively seeking enrollees for the clinical trials listed below. If you have questions about or are interested in participating in any of these trials, please call 646-501-0264.

Heart Valve Studies Seeking Enrollees

We are currently seeking participants for the following studies.

A Percutaneous Mitral Valve Replacement EvaLuation Utilizing IDE Early Feasibility Study (PRELUDE)

The purpose of this study is to assess the safety and performance of transcatheter mitral valve replacement (TMVR) for the treatment of severe symptomatic mitral regurgitation (MR). View full clinical trial information.

The PARTNER 3 Trial—A Prospective, Randomized, Controlled, Multicenter Study to Establish the Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low-Risk Patients who have Severe, Calcific, Aortic Stenosis Requiring Aortic Valve Replacement

The purpose of this study is to establish the safety and effectiveness of the Edwards SAPIEN 3 transcatheter heart valve in patients with severe, calcific aortic stenosis who are at low operative risk for standard aortic valve replacement (AVR). View full clinical trial information.

The PARTNER 3 Trial—A Prospective, Single-Arm, Multicenter Study to Investigate the Safety and Effectiveness of SAPIEN 3 Transcatheter Heart Valve Implantation in Patients with a Failing Mitral Bioprosthetic Valve

The purpose of this study is to assess the safety and effectiveness of the SAPIEN 3 transcatheter heart valve in patients with a failing mitral bioprosthetic valve. View full clinical trial information.

A Prospective, Single-Arm, Multicenter Study to Investigate the Safety and Effectiveness of SAPIEN 3 Transcatheter Heart Valve Implantation in Patients with a Failing Aortic Bioprosthetic Valve

The purpose of this study is to assess the safety and effectiveness of the SAPIEN 3 transcatheter heart valve in patients with a failing aortic bioprosthetic valve. View full clinical trial information.

A Prospective, Randomized, Controlled, Multicenter Study to Evaluate Transcatheter Aortic Valve Replacement Compared to SurveilLance for Patients with AsYmptomatic Severe Aortic Stenosis (EARLY TAVR)

The purpose of this study is to establish the safety and effectiveness of the Edwards SAPIEN 3 transcatheter heart valve compared with clinical surveillance (CS) in asymptomatic patients with severe, calcific aortic stenosis. View full clinical trial information.

A Randomized, Controlled Study to Assess Cardiovascular Outcomes of MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation

This is a prospective, multicenter, single-arm, continued access registry to evaluate the MitraClip® NT system for the treatment of clinically significant functional mitral regurgitation 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. View full clinical trial information.

A Contemporary, Prospective Study Evaluating Real-World Experience of Performance and Safety for the Next Generation of MitraClip Devices (EXPAND)

This is a study evaluating the use of the MitraClip® System in treatment of mitral regurgitation (MR). The MitraClip® system consists of a delivery catheter and an implantable clip that is designed to repair the mitral valve by clipping the two leaflets together. View full clinical trial information.

A Randomized Evaluation oF the TriGuard Embolic Deflection Device to Reduce the Impact of Cerebral Embolic LEsions After TransCatheter Aortic Valve ImplanTation (REFLECT)

The purpose of this study is to assess the safety and efficacy of the TriGuard HDH and TriGUARD 3 cerebral embolic protection devices in patients undergoing transcatheter aortic valve implantation/replacement (TAVI) in comparison with a control group of patients undergoing unprotected TAVI. View full clinical trial information.

A Prospective, Multicenter, Randomized, Controlled Pivotal Trial to Evaluate Annular ReduCtion for Transcatheter Treatment of Insufficient Mitral ValvE (ACTIVE)

The purpose of this study is to assess transcatheter mitral valve repair with the Edwards Cardioband system and guideline directed medical therapy (GDMT) compared to GDMT alone in patients with functional mitral regurgitation (FMR) and heart failure. View full clinical trial information.

A Prospective, Multicenter, Dual-Arm, Pivotal Clinical Study of the BioVentrix Revivent TC System for Treatment of Left Ventricular Aneurysms

The purpose of the study is to demonstrate the safety and effectiveness of the BioVentrix Revivent TC system for the treatment of LV antero-septal aneurysms/scars in patients with symptomatic heart failure. This is a prospective, multicenter, dual-arm pivotal study with 2:1 study versus active concurrent control group allocation ratio. View full clinical trial information.