Repair MR
for Severe Mitral Regurgitation
The prospective, randomized REPAIR MR clinical trial will enroll approximately 500 patients at 60 sites in the U.S., Canada and Europe to evaluate the effectiveness of the MitraClip device in moderate-surgical-risk patients with severe primary MR who are candidates for open-heart surgery, which is the current standard of care today. The trial’s design addresses the issue that, despite symptoms and increased mortality for people suffering from MR, patients are often undertreated by open-heart mitral valve surgery. Currently, only an estimated 15% of patients who are eligible for the standard-of-care surgery for their primary MR receive surgical treatment. In some cases, this may be because the MR goes undiagnosed, but in others, patients may forgo surgery due to prolonged recovery time or fear of possible surgical complications.
The objective of this randomized controlled trial (RCT) is to compare the clinical outcome of MitraClip™ device versus surgical repair in patients with severe primary MR who are at moderate surgical risk and whose mitral valve has been determined to be suitable for correction by MV repair surgery by the cardiac surgeon on the local site heart team.
Clinical Trials at RWJUH
Transcatheter aortic valve replacement vs OMM (randomized) for asymptomatic severe AS The EARLY TAVR trial (Edwards) looks at transcatheter aortic valve replacement (TAVR) as an effective treatment for patients with asymptomatic aortic stenosis. Patients are randomized to either treatment with TAVR or clinical surveillance until the develop symptoms, at which point they are eligible to be treated with TAVR. Read More
This study objective is to establish the safety and effectiveness of the Edwards SAPIEN 3/ SAPIEN 3 Ultra Transcatheter Heart Valve in subjects with moderate, calcific aortic stenosis. Patients are randomized to S3 TAVR device or medical management. Read More
ALIGN-AR evaluates the safety and probable benefit of the transfemoral JenaValve Pericardial TAVR System in patients with symptomatic severe aortic regurgitation. Patients who are high risk for open surgical aortic valve replacement/repair are eligible. RWJUH is one of only 15 centers in the U.S. that can offer this therapy that has been granted a “Breakthrough Device Designation” by the US Food and Drug Administration. This designation is reserved for investigative therapies designed to treat a serious or life-threatening disease or condition and where preliminary clinical evidence indicates that the therapy may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development. Read More
Transcatheter aortic valve replacement for severe AS with a novel deviceEvaluates the safety and efficacy of Acurate (Boston Scientific) valve for transcatheter aortic valve replacement. For patients with severe aortic stenosis who are at intermediate or greater risk for SAVR. Patients are randomized to Acurate or commerical TAVR device. Read More
The study is a prospective, multi-center, randomized controlled pivotal clinical trial to evaluate the safety and effectiveness of the EVOQUE System with optimal medical therapy (OMT) compared to OMT alone in the treatment of patients with at least severe tricuspid regurgitation. Subjects will be followed at discharge, 30 days, 3 months, 6 months and annually through 5 years. Read More
This study will establish the safety and effectiveness of the SAPIEN M3 System in subjects with symptomatic, at least 3+ mitral regurgitation (MR) for whom commercially available surgical or transcatheter treatment options are deemed unsuitable. Read More
CLASP IID/F is a prospective, multicenter, randomized, controlled pivotal trial to evaluate the safety and effectiveness of transcatheter mitral valve repair in patients with degenerative/functional mitral regurgitation with the Edwards PASCAL Transcatheter Valve Repair System compared with the commercially available device (Abbott MitraClip). Read More
The SUMMIT-Tendyne trial (Abbott) evaluates the safety and effectiveness of using the Tendyne Mitral Valve System for the treatment of symptomatic mitral regurgitation or mitral annular calcification in patients who are not appropriate for conventional mitral valve surgery. In the randomized arm, patients are treated with either the Tendyne device or MitraClip, while patients in the non-randomized and MAC arms receive the Tendyne device. Read More
The objective of this randomized controlled trial (RCT) is to compare the clinical outcome of MitraClip™ device versus surgical repair in patients with severe primary MR who are at moderate surgical risk and whose mitral valve has been determined to be suitable for correction by MV repair surgery by the cardiac surgeon on the local site heart team. Read More
This study will establish the safety and effectiveness of the SAPIEN M3 System in subjects with symptomatic, at least 3+ mitral regurgitation (MR) for whom commercially available surgical or transcatheter treatment options are deemed unsuitable. Read More
To schedule an in-person or telemedicine consult-ation with Dr. Russo, call 732-235-7231 or send an email
Dr. Russo is Professor of Surgery, Chief of Cardiac Surgery, and Director of Structural Heart Disease at Rutgers-Robert Wood Johnson Medical School
He is an internationally-known expert in the treatment of heart valve disease, and one of the most experienced transcatheter valve surgeons in the U.S. Dr. Russo specializes in complex and reoperative aortic and valvular surgery.
Dr. Russo has coauthored more than 200 published manuscripts, abstracts, and textbook chapters focused on improving health care quality, outcomes, and access for patients with cardiovascular disease.
Dr. Russo holds leadership roles for numerous national and international clinical trials. The findings of his work have been published in the New England Journal of Medicine (NEJM), the Lancet, the Journals of the American Medical Association (JAMA), and Circulation and reported by major media outlets, including the New York Times, Washington Post, ABC News, U.S. News & World Report, and Newsweek.
Transcatheter aortic valve replacement vs OMM (randomized) for asymptomatic severe AS The EARLY TAVR trial (Edwards) looks at transcatheter aortic valve replacement (TAVR) as an effective treatment for patients with asymptomatic aortic stenosis. Patients are randomized to either treatment with TAVR or clinical surveillance until the develop symptoms, at which point they are eligible to be treated with TAVR. Read More
This study objective is to establish the safety and effectiveness of the Edwards SAPIEN 3/ SAPIEN 3 Ultra Transcatheter Heart Valve in subjects with moderate, calcific aortic stenosis. Patients are randomized to S3 TAVR device or medical management. Read More
ALIGN-AR evaluates the safety and probable benefit of the transfemoral JenaValve Pericardial TAVR System in patients with symptomatic severe aortic regurgitation. Patients who are high risk for open surgical aortic valve replacement/repair are eligible. RWJUH is one of only 15 centers in the U.S. that can offer this therapy that has been granted a “Breakthrough Device Designation” by the US Food and Drug Administration. This designation is reserved for investigative therapies designed to treat a serious or life-threatening disease or condition and where preliminary clinical evidence indicates that the therapy may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development. Read More
Transcatheter aortic valve replacement for severe AS with a novel deviceEvaluates the safety and efficacy of Acurate (Boston Scientific) valve for transcatheter aortic valve replacement. For patients with severe aortic stenosis who are at intermediate or greater risk for SAVR. Patients are randomized to Acurate or commerical TAVR device. Read More
The study is a prospective, multi-center, randomized controlled pivotal clinical trial to evaluate the safety and effectiveness of the EVOQUE System with optimal medical therapy (OMT) compared to OMT alone in the treatment of patients with at least severe tricuspid regurgitation. Subjects will be followed at discharge, 30 days, 3 months, 6 months and annually through 5 years. Read More
This study will establish the safety and effectiveness of the SAPIEN M3 System in subjects with symptomatic, at least 3+ mitral regurgitation (MR) for whom commercially available surgical or transcatheter treatment options are deemed unsuitable. Read More
CLASP IID/F is a prospective, multicenter, randomized, controlled pivotal trial to evaluate the safety and effectiveness of transcatheter mitral valve repair in patients with degenerative/functional mitral regurgitation with the Edwards PASCAL Transcatheter Valve Repair System compared with the commercially available device (Abbott MitraClip). Read More
The SUMMIT-Tendyne trial (Abbott) evaluates the safety and effectiveness of using the Tendyne Mitral Valve System for the treatment of symptomatic mitral regurgitation or mitral annular calcification in patients who are not appropriate for conventional mitral valve surgery. In the randomized arm, patients are treated with either the Tendyne device or MitraClip, while patients in the non-randomized and MAC arms receive the Tendyne device. Read More
The objective of this randomized controlled trial (RCT) is to compare the clinical outcome of MitraClip™ device versus surgical repair in patients with severe primary MR who are at moderate surgical risk and whose mitral valve has been determined to be suitable for correction by MV repair surgery by the cardiac surgeon on the local site heart team. Read More
This study will establish the safety and effectiveness of the SAPIEN M3 System in subjects with symptomatic, at least 3+ mitral regurgitation (MR) for whom commercially available surgical or transcatheter treatment options are deemed unsuitable. Read More