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ACTIVE NOT RECRUITING

NCT04198870

MitraClip REPAIR MR Study

Sponsor: Abbott Medical Devices

View on ClinicalTrials.gov

Summary

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.

Official title: Percutaneous MitraClip Device or Surgical Mitral Valve REpair in PAtients With PrImaRy MItral Regurgitation Who Are Candidates for Surgery (REPAIR MR)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

500

Start Date

2020-07-21

Completion Date

2035-12

Last Updated

2025-11-12

Healthy Volunteers

Conditions

Mitral Valve Regurgitation

Interventions

DEVICE

MitraClip™ device implantation

Transcatheter repair of the mitral valve using MitraClip™ device

PROCEDURE

Mitral Valve Repair Surgery

Surgical repair of the mitral valve

Inclusion Criteria: 1. Subject has severe (Grade III or greater per the ASE criteria, which includes severity grades of 3+ and 4+) primary MR (mixed etiology is acceptable provided the principal mechanism of action is a degenerative mitral valve) as assessed by the ECL. 2. The cardiac surgeon of the Site Heart Team (consisting of at least one interventionalist, and one cardiac surgeon) has confirmed that the subject is a candidate for mitral valve surgery and the EC have confirmed that the subject's mitral valve anatomy is suitable for percutaneous repair with the MitraClip™ device with high certainty of achieving MR ≤ mild 3. Subject is symptomatic (NYHA Class II/III/IV) or asymptomatic with LVEF ≤ 60%, pulmonary artery systolic pressure \> 50 mmHg, or LVESD \> 40 mm 4. Subject is at moderate surgical risk defined as being at least 75 years of age at the time of EC review. If younger than 75 years, then the subject should have: 1. Society of Thoracic Surgeons (STS) Predicted Risk of Mortality (PROM) Repair Score ≥ 2%, OR 2. Presence of other comorbidities which may introduce a potential surgery-specific impediment 5. Subject provides written informed consent 6. Subject is ≥ 18 years of age Exclusion Criteria: 1. Subject is currently participating in another clinical investigation 2. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results. 3. Subject has ischemic or non-ischemic secondary MR 4. Concomitant severe tricuspid valve regurgitation 5. Ejection fraction \<30% 6. Severe mitral annular calcification 7. Acute myocardial infarction in the past 12 weeks 8. Need for cardiac surgery to correct pulmonary valve disease, aortic valve disease, or tricuspid valve disease 9. Subjects who have concurrent coronary artery disease that needs to be treated may be included provided the subjects are eligible for both percutaneous coronary intervention (PCI) and coronary artery bypass surgery. Subjects randomized to the device group, must undergo PCI before the MitraClip™ device procedure. Subjects randomized to the surgical (control) arm may undergo coronary artery revascularization during mitral valve repair surgery 10. Surgical procedure performed in the past 30 days 11. Femoral vein cannot accommodate a 24 F catheter or presence of IVC filter would interfere with the catheter or ipsilateral DVT 12. Transesophageal echocardiography (TEE) is contraindicated. 13. Hemodynamic instability: systolic pressure ≤ 90 mmHg without afterload reduction, cardiogenic shock, or the need for inotropic support or IABP 14. Need for emergency surgery for any reason 15. Prior mitral valve surgery, valvuloplasty, mechanical prosthetic valve or VAD 16. Systolic anterior motion of the mitral valve 17. Hypertrophic cardiomyopathy 18. Renal insufficiency requiring dialysis 19. Active infections requiring current antibiotic therapy

Locations (74)

University Hospital - Univ. of Alabama at Birmingham (UAB)

Birmingham, Alabama, United States

Cardiology Associates of Mobile, Inc.

Mobile, Alabama, United States

Banner-University Medical Center Phoenix

Phoenix, Arizona, United States

St. Josephs Hospital and Medical Center

Phoenix, Arizona, United States

Arizona Cardiovascular Research Center

Phoenix, Arizona, United States

Tucson Medical Center

Tucson, Arizona, United States

Scripps Health

La Jolla, California, United States

Sutter Medical Center, Sacramento

Sacramento, California, United States

University of California - Davis Medical Center

Sacramento, California, United States

Mercy General Hospital

Sacramento, California, United States

University of California at San Francisco

San Francisco, California, United States

Stanford University Medical Center

Stanford, California, United States

Los Robles Regional Medical Center

Thousand Oaks, California, United States

Saint Joseph Hospital

Denver, Colorado, United States

Yale New Haven Hospital

New Haven, Connecticut, United States

Baptist Medical Center

Jacksonville, Florida, United States

NCH Healthcare System

Naples, Florida, United States

Piedmont Heart Institute

Atlanta, Georgia, United States

Northwestern Memorial Hospital

Chicago, Illinois, United States

Prairie Education & Research Cooperative

Springfield, Illinois, United States

Ascension St. Vincent

Indianapolis, Indiana, United States

Kansas University Medical Center

Kansas City, Kansas, United States

Via Christi Regional Medical Center - St. Francis Campus

Wichita, Kansas, United States

Cardiovascular Research Institute of Kansas

Wichita, Kansas, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

University of Michigan Medical Center

Ann Arbor, Michigan, United States

Henry Ford Health

Detroit, Michigan, United States

Beaumont Hospital, Royal Oak

Royal Oak, Michigan, United States

Abbott Northwestern Hospital

Minneapolis, Minnesota, United States

Cooper University Hospital

Camden, New Jersey, United States

Morristown Medical Center

Morristown, New Jersey, United States

Jersey Shore University Medical Center

Neptune City, New Jersey, United States

Albany Medical Center

Albany, New York, United States

South Shore University Hospital

Bay Shore, New York, United States

NYU Langone Health

New York, New York, United States

New York-Presbyterian/Columbia University Medical Center

New York, New York, United States

Rochester Regional Health

Rochester, New York, United States

St. Francis Hospital

Roslyn, New York, United States

Mission Health & Hospitals

Asheville, North Carolina, United States

Carolinas Medical Center

Charlotte, North Carolina, United States

Duke University Medical Center

Durham, North Carolina, United States

Christ Hospital

Cincinnati, Ohio, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Mt. Carmel East

Columbus, Ohio, United States

Integris Baptist Medical Center

Oklahoma City, Oklahoma, United States

Pinnacle Health Cardiovascular Institute, Inc.

Harrisburg, Pennsylvania, United States

Allegheny General Hospital - ASRI

Pittsburgh, Pennsylvania, United States

UPMC

Pittsburgh, Pennsylvania, United States

Lankenau Institute for Medical Research

Wynnewood, Pennsylvania, United States

TriStar Centennial Medical Center

Nashville, Tennessee, United States

Ascension Saint Thomas

Nashville, Tennessee, United States

Vanderbilt Heart & Vascular Institute

Nashville, Tennessee, United States

Ascension Texas Cardiovascular Research

Austin, Texas, United States

HCA Houston Healthcare Medical Center

Houston, Texas, United States

UTHealth Memorial Hermann

Houston, Texas, United States

Houston Methodist

Houston, Texas, United States

Intermountain Medical Center

Murray, Utah, United States

University of Virginia Medical Center

Charlottesville, Virginia, United States

Sentara Norfolk General Hospital

Norfolk, Virginia, United States

Swedish Medical Center

Seattle, Washington, United States

The Heart Institute at Virginia Mason

Seattle, Washington, United States

West Virginia University Hospital

Morgantown, West Virginia, United States

St. Michael's Hospital

Toronto, Ontario, Canada

Toronto General Hospital

Toronto, Ontario, Canada

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Institut de Cardiologie de Montreal (Montreal Heart Inst.)

Montreal, Quebec, Canada

Universitätsklinikum Ulm

Ulm, Bad-wur, Germany

Klinikum der Johann Wolfgang Goethe-Universität Frankfurt

Frankfurt am Main, Hesse, Germany

Herz-und Diabetes Zentrum NRW

Bad Oeynhausen, North Rhine-Westphalia, Germany

Universitätsmedizin der Johannes Gutenberg-Universität Mainz

Mainz, Rhinela, Germany

Deutsches Herzzentrum München des Freistaates Bayern

München, Germany

Universitätsklinikum Rostock (AöR)

Rostock, Germany

Center Inselspital Bern

Bern, Canton of Bern, Switzerland

Clinical Research Directory

MitraClip REPAIR MR Study

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (74)