MitraClip REPAIR MR Study

Last updated: April 29, 2025
Sponsor: Abbott Medical Devices
Overall Status: Active - Recruiting

Phase

N/A

Condition

Mitral Valve Regurgitation

Treatment

MitraClip™ device implantation

Mitral Valve Repair Surgery

Clinical Study ID

NCT04198870
ABT-CIP-10304
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  1. Subject has severe (Grade III or greater per the ASE criteria, which includesseverity grades of 3+ and 4+) primary MR (mixed etiology is acceptable provided theprincipal mechanism of action is a degenerative mitral valve) as assessed by theECL.

  2. The cardiac surgeon of the Site Heart Team (consisting of at least oneinterventionalist, and one cardiac surgeon) has confirmed that the subject is acandidate for mitral valve surgery and the EC have confirmed that the subject'smitral valve anatomy is suitable for percutaneous repair with the MitraClip™ devicewith 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 atthe time of EC review. If younger than 75 years, then the subject should have:

  5. Society of Thoracic Surgeons (STS) Predicted Risk of Mortality (PROM) RepairScore ≥ 2%, OR

  6. Presence of other comorbidities which may introduce a potentialsurgery-specific impediment

  7. Subject provides written informed consent

  8. Subject is ≥ 18 years of age

Exclusion

Exclusion Criteria:

  1. Subject is currently participating in another clinical investigation

  2. Presence of other anatomic or comorbid conditions, or other medical, social, orpsychological conditions that, in the investigator's opinion, could limit thesubject's ability to participate in the clinical investigation or to comply withfollow-up requirements, or impact the scientific soundness of the clinicalinvestigation 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 beincluded provided the subjects are eligible for both percutaneous coronaryintervention (PCI) and coronary artery bypass surgery. Subjects randomized to thedevice group, must undergo PCI before the MitraClip™ device procedure. Subjectsrandomized to the surgical (control) arm may undergo coronary arteryrevascularization 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 wouldinterfere 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

Study Design

Total Participants: 500
Treatment Group(s): 2
Primary Treatment: MitraClip™ device implantation
Phase:
Study Start date:
July 21, 2020
Estimated Completion Date:
April 30, 2034

Connect with a study center

  • Ottawa Heart Institute

    Ottawa, Ontario K1Y 4W7
    Canada

    Site Not Available

  • St. Michael's Hospital

    Toronto, Ontario M5B 1W8
    Canada

    Active - Recruiting

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario M5N 3M5
    Canada

    Active - Recruiting

  • Toronto General Hospital

    Toronto, Ontario M5G 2C4
    Canada

    Active - Recruiting

  • Institut de Cardiologie de Montreal (Montreal Heart Inst.)

    Montréal, Quebec H1T 1C8
    Canada

    Active - Recruiting

  • Universitätsklinikum Ulm

    Ulm, Bad-wur 89081
    Germany

    Active - Recruiting

  • Klinikum der Johann Wolfgang Goethe-Universität Frankfurt

    Frankfurt am Main, Hessen 60590
    Germany

    Active - Recruiting

  • Herz-und Diabetes Zentrum NRW

    Bad Oeynhausen, North Rhine-Westphalia 32545
    Germany

    Active - Recruiting

  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz

    Mainz, Rhinela 55131
    Germany

    Active - Recruiting

  • Herzzentrum Leipzig GmbH

    Leipzig, Saxony 04289
    Germany

    Site Not Available

  • Deutsches Herzzentrum München des Freistaates Bayern

    München, 80636
    Germany

    Active - Recruiting

  • Universitätsklinikum Rostock (AöR)

    Rostock, 18057
    Germany

    Active - Recruiting

  • Ospedale San Raffaele - Cardiac

    Milano, Lombard 20132
    Italy

    Site Not Available

  • Policlinico San Donato

    San Donato Milanese, Lombard 20097
    Italy

    Site Not Available

  • Center Inselspital Bern

    Bern, 3010
    Switzerland

    Active - Recruiting

  • University Hospital - Univiversity of Alabama at Birmingham

    Birmingham, Alabama 35249
    United States

    Active - Recruiting

  • Cardiology Associates of Mobile, Inc.

    Mobile, Alabama 36608
    United States

    Active - Recruiting

  • Arizona Cardiovascular Research Center

    Phoenix, Arizona 85016
    United States

    Terminated

  • Banner-University Medical Center Phoenix

    Phoenix, Arizona 85006
    United States

    Active - Recruiting

  • St. Joseph's Hospital & Medical Center

    Phoenix, Arizona 85013
    United States

    Site Not Available

  • St. Josephs Hospital and Medical Center

    Phoenix, Arizona 85013
    United States

    Active - Recruiting

  • Tucson Medical Center

    Tucson, Arizona 85712
    United States

    Active - Recruiting

  • Scripps Memorial Hospital La Jolla

    La Jolla, California 92037
    United States

    Active - Recruiting

  • Cedars-Sinai Medical Center

    Los Angeles, California 90048
    United States

    Site Not Available

  • Mercy General Hospital

    Sacramento, California 95819
    United States

    Active - Recruiting

  • Sutter Medical Center, Sacramento

    Sacramento, California 95816
    United States

    Active - Recruiting

  • UC Davis Medical Center

    Sacramento, California 95817
    United States

    Active - Recruiting

  • University of California at San Francisco

    San Francisco, California 94143
    United States

    Active - Recruiting

  • Stanford University Medical Center

    Stanford, California 94305
    United States

    Active - Recruiting

  • Los Robles Regional Medical Center

    Thousand Oaks, California 91360
    United States

    Active - Recruiting

  • Saint Joseph Hospital

    Denver, Colorado 80218
    United States

    Active - Recruiting

  • Yale New Haven Hospital

    New Haven, Connecticut 06510
    United States

    Active - Recruiting

  • Manatee Memorial Hospital

    Bradenton, Florida 34208
    United States

    Site Not Available

  • Baptist Medical Center

    Jacksonville, Florida 32207
    United States

    Active - Recruiting

  • NCH Healthcare System

    Naples, Florida 34102
    United States

    Active - Recruiting

  • AdventHealth Orlando

    Orlando, Florida 33019
    United States

    Site Not Available

  • Piedmont Heart Institute

    Atlanta, Georgia 30309
    United States

    Active - Recruiting

  • WellStar Kennestone Hospital

    Marietta, Georgia 30060
    United States

    Site Not Available

  • Northwestern Memorial Hospital

    Chicago, Illinois 60611
    United States

    Active - Recruiting

  • Prairie Education & Research Cooperative

    Springfield, Illinois 62701
    United States

    Active - Recruiting

  • St. Vincent Hospital

    Indianapolis, Indiana 46240
    United States

    Active - Recruiting

  • Kansas University Medical Center

    Kansas City, Kansas 66160
    United States

    Active - Recruiting

  • Cardiovascular Research Institute of Kansas

    Wichita, Kansas 67226
    United States

    Active - Recruiting

  • Via Christi Regional Medical Center - St. Francis Campus

    Wichita, Kansas 67214
    United States

    Active - Recruiting

  • Brigham & Women's Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • University of Michigan

    Ann Arbor, Michigan 48104
    United States

    Active - Recruiting

  • Henry Ford Hospital

    Detroit, Michigan 48202
    United States

    Active - Recruiting

  • Beaumont Hospital, Royal Oak

    Royal Oak, Michigan 48073
    United States

    Active - Recruiting

  • Abbott Northwestern Hospital

    Minneapolis, Minnesota 55407
    United States

    Active - Recruiting

  • Cooper University Hospital

    Camden, New Jersey 08103
    United States

    Active - Recruiting

  • Atlantic Health System - Morristown Memorial Hospital

    Morristown, New Jersey 07962
    United States

    Active - Recruiting

  • Jersey Shore University Medical Center

    Neptune, New Jersey 07753
    United States

    Active - Recruiting

  • Robert Wood Johnson University Hospital

    New Brunswick, New Jersey 08901
    United States

    Site Not Available

  • Albany Medical Center

    Albany, New York 12208
    United States

    Active - Recruiting

  • South Shore University Hospital

    Bay Shore, New York 11706
    United States

    Active - Recruiting

  • Southside Hospital - Northwell Health

    Bay Shore, New York 11706
    United States

    Site Not Available

  • Buffalo General Hospital

    Buffalo, New York 14203
    United States

    Site Not Available

  • NYU Langone Medical Center

    New York, New York 10016
    United States

    Active - Recruiting

  • New York-Presbyterian/Columbia University Medical Center

    New York, New York 10032
    United States

    Active - Recruiting

  • Rochester Regional Health

    Rochester, New York 14617
    United States

    Active - Recruiting

  • St. Francis Hospital

    Roslyn, New York 11576
    United States

    Active - Recruiting

  • Mission Health & Hospitals

    Asheville, North Carolina 28801
    United States

    Active - Recruiting

  • Carolinas Medical Center

    Charlotte, North Carolina 28203
    United States

    Active - Recruiting

  • Duke University Medical Center

    Durham, North Carolina 27705
    United States

    Active - Recruiting

  • Christ Hospital

    Cincinnati, Ohio 45219
    United States

    Active - Recruiting

  • The Cleveland Clinic Foundation

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio 44106
    United States

    Active - Recruiting

  • Mt. Carmel East

    Columbus, Ohio 43213
    United States

    Active - Recruiting

  • Integris Baptist Medical Center

    Oklahoma City, Oklahoma 73112
    United States

    Active - Recruiting

  • Pinnacle Health System

    Harrisburg, Pennsylvania 17105
    United States

    Active - Recruiting

  • Allegheny General Hospital - ASRI

    PIttsburg, Pennsylvania 15212
    United States

    Active - Recruiting

  • Allegheny General Hospital - ASRI

    Pittsburgh, Pennsylvania 15212
    United States

    Active - Recruiting

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania 15213
    United States

    Active - Recruiting

  • Lankenau Institute for Medical Research

    Wynnewood, Pennsylvania 19096
    United States

    Active - Recruiting

  • Centennial Medical Center

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • St Thomas Hospital

    Nashville, Tennessee 37205
    United States

    Active - Recruiting

  • Vanderbilt Heart & Vascular Institute

    Nashville, Tennessee 37232
    United States

    Active - Recruiting

  • Ascension Texas Cardiovascular

    Austin, Texas 78705
    United States

    Active - Recruiting

  • Austin Heart

    Austin, Texas 78756
    United States

    Site Not Available

  • Memorial Hermann Hospital

    Houston, Texas 77008
    United States

    Active - Recruiting

  • Park Plaza Hospital/HCA Hospital of Houston

    Houston, Texas 77004
    United States

    Active - Recruiting

  • The Methodist Hospital

    Houston, Texas 77030
    United States

    Active - Recruiting

  • The Heart Hospital Baylor Plano

    Plano, Texas 75093
    United States

    Site Not Available

  • Intermountain Medical Center

    Murray, Utah 84157
    United States

    Active - Recruiting

  • University of Virginia Medical Center

    Charlottesville, Virginia 22908
    United States

    Active - Recruiting

  • Sentara Norfolk General Hospital

    Norfolk, Virginia 23507
    United States

    Active - Recruiting

  • Swedish Medical Center

    Seattle, Washington 98107
    United States

    Active - Recruiting

  • The Heart Institute at Virginia Mason

    Seattle, Washington 98111
    United States

    Active - Recruiting

  • West Virginia University Hospital

    Morgantown, West Virginia 26506
    United States

    Site Not Available

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