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

Status: Recruiting
Location: See all (85) locations...
Intervention Type: Device, Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

• 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

• Subject is symptomatic (NYHA Class II/III/IV) or asymptomatic with LVEF ≤ 60%, pulmonary artery systolic pressure \> 50 mmHg, or LVESD \> 40 mm

• 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:

‣ Society of Thoracic Surgeons (STS) Predicted Risk of Mortality (PROM) Repair Score ≥ 2%, OR

⁃ Presence of other comorbidities which may introduce a potential surgery-specific impediment

• Subject provides written informed consent

• Subject is ≥ 18 years of age

Locations
United States
Alabama
University Hospital - Univiversity of Alabama at Birmingham
RECRUITING
Birmingham
Cardiology Associates of Mobile, Inc.
RECRUITING
Mobile
Arizona
Arizona Cardiovascular Research Center
TERMINATED
Phoenix
Banner-University Medical Center Phoenix
RECRUITING
Phoenix
St. Josephs Hospital and Medical Center
RECRUITING
Phoenix
Tucson Medical Center
RECRUITING
Tucson
California
Scripps Memorial Hospital La Jolla
RECRUITING
La Jolla
Cedars-Sinai Medical Center
WITHDRAWN
Los Angeles
Mercy General Hospital
RECRUITING
Sacramento
Sutter Medical Center, Sacramento
RECRUITING
Sacramento
UC Davis Medical Center
RECRUITING
Sacramento
University of California at San Francisco
RECRUITING
San Francisco
Stanford University Medical Center
RECRUITING
Stanford
Los Robles Regional Medical Center
RECRUITING
Thousand Oaks
Colorado
Saint Joseph Hospital
RECRUITING
Denver
Connecticut
Yale New Haven Hospital
RECRUITING
New Haven
Florida
Manatee Memorial Hospital
WITHDRAWN
Bradenton
Baptist Medical Center
RECRUITING
Jacksonville
NCH Healthcare System
RECRUITING
Naples
AdventHealth Orlando
WITHDRAWN
Orlando
Georgia
Piedmont Heart Institute
RECRUITING
Atlanta
WellStar Kennestone Hospital
WITHDRAWN
Marietta
Illinois
Northwestern Memorial Hospital
RECRUITING
Chicago
Prairie Education & Research Cooperative
RECRUITING
Springfield
Indiana
St. Vincent Hospital
RECRUITING
Indianapolis
Kansas
Kansas University Medical Center
RECRUITING
Kansas City
Cardiovascular Research Institute of Kansas
RECRUITING
Wichita
Via Christi Regional Medical Center - St. Francis Campus
RECRUITING
Wichita
Massachusetts
Brigham & Women's Hospital
ACTIVE_NOT_RECRUITING
Boston
Massachusetts General Hospital
RECRUITING
Boston
Michigan
University of Michigan
RECRUITING
Ann Arbor
Henry Ford Hospital
RECRUITING
Detroit
Beaumont Hospital, Royal Oak
RECRUITING
Royal Oak
Minnesota
Abbott Northwestern Hospital
RECRUITING
Minneapolis
North Carolina
Mission Health & Hospitals
RECRUITING
Asheville
Carolinas Medical Center
RECRUITING
Charlotte
Duke University Medical Center
RECRUITING
Durham
New Jersey
Cooper University Hospital
RECRUITING
Camden
Atlantic Health System - Morristown Memorial Hospital
RECRUITING
Morristown
Jersey Shore University Medical Center
RECRUITING
Neptune City
Robert Wood Johnson University Hospital
WITHDRAWN
New Brunswick
New York
Albany Medical Center
RECRUITING
Albany
South Shore University Hospital
RECRUITING
Bay Shore
Buffalo General Hospital
WITHDRAWN
Buffalo
New York-Presbyterian/Columbia University Medical Center
RECRUITING
New York
NYU Langone Medical Center
RECRUITING
New York
Rochester Regional Health
RECRUITING
Rochester
St. Francis Hospital
RECRUITING
Roslyn
Ohio
Christ Hospital
RECRUITING
Cincinnati
The Cleveland Clinic Foundation
WITHDRAWN
Cleveland
University Hospitals Cleveland Medical Center
RECRUITING
Cleveland
Mt. Carmel East
RECRUITING
Columbus
Oklahoma
Integris Baptist Medical Center
RECRUITING
Oklahoma City
Pennsylvania
Pinnacle Health System
RECRUITING
Harrisburg
Allegheny General Hospital - ASRI
RECRUITING
Pittsburgh
University of Pittsburgh Medical Center
RECRUITING
Pittsburgh
Lankenau Institute for Medical Research
RECRUITING
Wynnewood
Tennessee
Centennial Medical Center
RECRUITING
Nashville
St Thomas Hospital
RECRUITING
Nashville
Vanderbilt Heart & Vascular Institute
RECRUITING
Nashville
Texas
Ascension Texas Cardiovascular
RECRUITING
Austin
Austin Heart
WITHDRAWN
Austin
Memorial Hermann Hospital
RECRUITING
Houston
Park Plaza Hospital/HCA Hospital of Houston
RECRUITING
Houston
The Methodist Hospital
RECRUITING
Houston
The Heart Hospital Baylor Plano
WITHDRAWN
Plano
Utah
Intermountain Medical Center
RECRUITING
Murray
Virginia
University of Virginia Medical Center
RECRUITING
Charlottesville
Sentara Norfolk General Hospital
RECRUITING
Norfolk
Washington
Swedish Medical Center
RECRUITING
Seattle
The Heart Institute at Virginia Mason
RECRUITING
Seattle
West Virginia
West Virginia University Hospital
ACTIVE_NOT_RECRUITING
Morgantown
Other Locations
Canada
Institut de Cardiologie de Montreal (Montreal Heart Inst.)
RECRUITING
Montreal
Ottawa Heart Institute
WITHDRAWN
Ottawa
St. Michael's Hospital
RECRUITING
Toronto
Sunnybrook Health Sciences Centre
RECRUITING
Toronto
Toronto General Hospital
RECRUITING
Toronto
Germany
Herz-und Diabetes Zentrum NRW
RECRUITING
Bad Oeynhausen
Klinikum der Johann Wolfgang Goethe-Universität Frankfurt
RECRUITING
Frankfurt Am Main
Herzzentrum Leipzig GmbH
WITHDRAWN
Leipzig
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
RECRUITING
Mainz
Deutsches Herzzentrum München des Freistaates Bayern
RECRUITING
München
Universitätsklinikum Rostock (AöR)
RECRUITING
Rostock
Universitätsklinikum Ulm
RECRUITING
Ulm
Switzerland
Center Inselspital Bern
RECRUITING
Bern
Contact Information
Primary
Janna Joyner
janna.joyner@abbott.com
(919) 971 4537
Time Frame
Start Date: 2020-07-21
Estimated Completion Date: 2034-04
Participants
Target number of participants: 500
Treatments
Other: Control Arm
Mitral Valve Repair Surgery
Experimental: Device Arm
MitraClip™ device implantation
Related Therapeutic Areas
Sponsors
Leads: Abbott Medical Devices

This content was sourced from clinicaltrials.gov