Penn Heart and Vascular

Clinical Trials at the Heart Valve Disease Program

Clinical Trials

Valve Disease

The PARTNER Transcatheter AVR Trial

Penn Medicine was one of the first sites to participate in and was a leading enrollment site for the Placement of Aortic Transcatheter Valves (PARTNER) trial comparing the safety and effectiveness of the Edwards SAPIEN® transcatheter heart valve to that of standard valve replacement surgery (cohort A) or "non-operative" patients (cohort B) in high-risk, symptomatic patients with severe aortic stenosis. In the PARTNER trial, cohort B showed the rate of death from cardiovascular causes at one year (Kaplan–Meier analysis) was also lower in the transcatheter aortic-valve implantation (TAVI*) group than in the standard therapy group.
* TAVI procedure is now referred to as TAVR (transcatheter aortic valve replacement).

Learn more about the PARTNER Transcatheter AVR Trial

The PARTNER Trial: Phase II

PARTNER II, will evaluate the SAPIEN XT transcatheter aortic valve in high-risk, symptomatic patients with severe aortic stenosis. The Sapien XT valve has a lower profile than its predecessor that can be delivered through an 18F sheath, permitting stent placement for the broad population of patients with smaller femoral arteries who were previously excluded from stent therapy.

Learn more about the PARTNER Trial: Phase II

Everest II

The EVEREST II trial examined the use of the MitraClip for the percutaneous repair of mitral valve regurgitation in patients with moderately severe or severe mitral regurgitation. The Hospital of the University of Pennsylvania was among the first in the nation to perform percutaneous repair for mitral valve regurgitation in 2005 and is one of only 37 hospitals nationwide (and the only one in the region) using the MitraClip device. The trial's PI is Howard C. Herrmann, MD.

Learn more about Everest II

National Heart Lung and Blood Institute (NHLBI) in conjunction with the Cardiothoracic Surgical Trials Network (CTSN)
Evaluation of Outcomes Following Mitral Valve Repair/Replacement in Severe Chronic Ischemic Mitral Valve Regurgitation

Penn Medicine was one of the first sites to participate in and is the leading enrollment site throughout the CTSN for this trial. The primary aim of this trial compares mitral valve repair with annuloplasty and a sub-valvular procedure for severe tethering to mitral valve replacement and complete preservation of the sub-valvular apparatus to evaluate the impact of these two surgical approaches on the degree of left ventricular remodeling and cardiac performance.

National Heart Lung and Blood Institute (NHLBI) in conjunction with the Cardiothoracic Surgical Trials Network (CTSN)
Surgical Interventions for Moderate Ischemic Mitral Regurgitation

The overall objective of this trial is to compare mitral valve repair combined with coronary artery bypass grafting to coronary artery bypass grafting alone to evaluate the impact of these two surgical approaches on the degree of left ventricular remodeling and cardiac performance.

Placement of Aortic Transcatheter valves (PARTNER) trial

This trial examines the use of transcatheter aortic-valve implantation (TAVI) in high-risk patients with severe aortic stenosis considered unsuitable candidates for surgery.

ATS 3f® Aortic Bioprosthesis Model 1000 Post-approval Study

This clinical study seeks to determine whether in younger patients (<60 years of age) implanted with the model 1000 whether an increased incidence and rate of aortic regurgitation occurs when undergoing isolated aortic valve replacement of the native aortic valve or replacement of a failed prosthesis.

The Sorin 3D Annuloplasty Ring For Mitral Repair

The purpose of this study is to collect data on the effectiveness and clinical outcomes of the MEMO 3D™ annuloplasty ring as used for mitral valve repair.

Mitroflow® vs. Magna Randomized Study

A randomized study to compare sizing, implant techniques and hemodynamic performance between the Mitroflow® Pericardial Aortic Valve and the Edwards Magna Heart Valve in the aortic position to determine which of the valve types provides lower pressure gradients relative to the aortic annulus.

AMPLATZER® Cardiac Plug (ACP) Clinical Trial

The ACP trial is designed to evaluate the safety and effectiveness of the AMPLATZER® Cardiac Plug for left atrial appendage closure (investigational device) in people with non-valvular atrial fibrillation compared to the use of warfarin.

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