MitraClip REPAIR MR Study

NCT04198870 | Active Not Recruiting DMC FDA Device

• 1 other identifier: ABT-CIP-10304
• Study Type: interventional
• Target: 500
• Locations: 4 countries
• Sites: 74

Brief 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.

Conditions

Mitral Valve Regurgitation

Keywords

MitraClip

Outcome Measures

Primary Outcomes (2)

• All-cause mortality, stroke, cardiac hospitalization, or acute kidney injury requiring renal replacement therapy at 2 years (any cardiac hospitalizations in the first 30 days post treatment will be excluded)

  The proportion of subjects who are alive, without stroke, CV hospitalization or acute kidney injury requiring renal replacement therapy at 2 years in the Device and Control groups, respectively

  2 Years

• Proportion of subjects with moderate or less MR (≤2+), without mitral valve replacement, and without recurrent mitral valve intervention (surgical or percutaneous)

  Proportion of subjects with moderate or less MR (≤2+), without mitral valve replacement, and without recurrent mitral valve intervention (surgical or percutaneous) from the time of index procedure through 2 years in the Device and Control groups, respectively

  2 Years

Secondary Outcomes (5)

• Proportion of subjects with MR ≤ mild at 30 days post index procedure among survivors

  30 Days

• Number of days at hospital from index procedure to home discharge

  At Discharge (≤ 14 days following index procedure)

• Proportion of subjects discharged to home post index hospitalization

  At Discharge (≤ 14 days following index procedure)

• Quality of life improvement assessed using the Kansas City Cardiomyopathy Questionnaire (KCCQ) of at least 10 points at 2 years compared to baseline among survivors.

  2 Years

• Severe symptomatic mitral stenosis at 1 year

  1 Year

Study Arms (2)

Control Arm

OTHER

Mitral Valve Repair Surgery

Procedure: Mitral Valve Repair Surgery

Device Arm

EXPERIMENTAL

MitraClip™ device implantation

Device: MitraClip™ device implantation

Interventions

MitraClip™ device implantation DEVICE

Transcatheter repair of the mitral valve using MitraClip™ device

Device Arm

Mitral Valve Repair Surgery PROCEDURE

Surgical repair of the mitral valve

Control Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Subject is currently participating in another clinical investigation
• 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.
• Subject has ischemic or non-ischemic secondary MR
• Concomitant severe tricuspid valve regurgitation
• Ejection fraction \<30%
• Severe mitral annular calcification
• Acute myocardial infarction in the past 12 weeks
• Need for cardiac surgery to correct pulmonary valve disease, aortic valve disease, or tricuspid valve disease
• 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
• Surgical procedure performed in the past 30 days
• Femoral vein cannot accommodate a 24 F catheter or presence of IVC filter would interfere with the catheter or ipsilateral DVT
• Transesophageal echocardiography (TEE) is contraindicated.
• Hemodynamic instability: systolic pressure ≤ 90 mmHg without afterload reduction, cardiogenic shock, or the need for inotropic support or IABP
• Need for emergency surgery for any reason
• Prior mitral valve surgery, valvuloplasty, mechanical prosthetic valve or VAD

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (74)

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

Birmingham, Alabama, 35249, United States

Location

Cardiology Associates of Mobile, Inc.

Mobile, Alabama, 36608, United States

Location

Banner-University Medical Center Phoenix

Phoenix, Arizona, 85006, United States

Location

St. Josephs Hospital and Medical Center

Phoenix, Arizona, 85013, United States

Location

Arizona Cardiovascular Research Center

Phoenix, Arizona, 85016, United States

Location

Tucson Medical Center

Tucson, Arizona, 85712, United States

Location

Scripps Health

La Jolla, California, 92037, United States

Location

Sutter Medical Center, Sacramento

Sacramento, California, 95816, United States

Location

University of California - Davis Medical Center

Sacramento, California, 95817, United States

Location

Mercy General Hospital

Sacramento, California, 95819, United States

Location

University of California at San Francisco

San Francisco, California, 94143, United States

Location

Stanford University Medical Center

Stanford, California, 94305, United States

Location

Los Robles Regional Medical Center

Thousand Oaks, California, 91360, United States

Location

Saint Joseph Hospital

Denver, Colorado, 80218, United States

Location

Yale New Haven Hospital

New Haven, Connecticut, 06510, United States

Location

Baptist Medical Center

Jacksonville, Florida, 32207, United States

Location

NCH Healthcare System

Naples, Florida, 34102, United States

Location

Piedmont Heart Institute

Atlanta, Georgia, 30309, United States

Location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Prairie Education & Research Cooperative

Springfield, Illinois, 62701, United States

Location

Ascension St. Vincent

Indianapolis, Indiana, 46240, United States

Location

Kansas University Medical Center

Kansas City, Kansas, 66160, United States

Location

Via Christi Regional Medical Center - St. Francis Campus

Wichita, Kansas, 67214, United States

Location

Cardiovascular Research Institute of Kansas

Wichita, Kansas, 67226, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

University of Michigan Medical Center

Ann Arbor, Michigan, 48104, United States

Location

Henry Ford Health

Detroit, Michigan, 48202, United States

Location

Beaumont Hospital, Royal Oak

Royal Oak, Michigan, 48073, United States

Location

Abbott Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

Location

Cooper University Hospital

Camden, New Jersey, 08103, United States

Location

Morristown Medical Center

Morristown, New Jersey, 07962, United States

Location

Jersey Shore University Medical Center

Neptune City, New Jersey, 07753, United States

Location

Albany Medical Center

Albany, New York, 12208, United States

Location

South Shore University Hospital

Bay Shore, New York, 11706, United States

Location

NYU Langone Health

New York, New York, 10016, United States

Location

New York-Presbyterian/Columbia University Medical Center

New York, New York, 10032, United States

Location

Rochester Regional Health

Rochester, New York, 14617, United States

Location

St. Francis Hospital

Roslyn, New York, 11576, United States

Location

Mission Health & Hospitals

Asheville, North Carolina, 28801, United States

Location

Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

Location

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Mt. Carmel East

Columbus, Ohio, 43213, United States

Location

Integris Baptist Medical Center

Oklahoma City, Oklahoma, 73112, United States

Location

Pinnacle Health Cardiovascular Institute, Inc.

Harrisburg, Pennsylvania, 17105, United States

Location

Allegheny General Hospital - ASRI

Pittsburgh, Pennsylvania, 15212, United States

Location

UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

Lankenau Institute for Medical Research

Wynnewood, Pennsylvania, 19096, United States

Location

TriStar Centennial Medical Center

Nashville, Tennessee, 37203, United States

Location

Ascension Saint Thomas

Nashville, Tennessee, 37205, United States

Location

Vanderbilt Heart & Vascular Institute

Nashville, Tennessee, 37232, United States

Location

Ascension Texas Cardiovascular Research

Austin, Texas, 78705, United States

Location

HCA Houston Healthcare Medical Center

Houston, Texas, 77004, United States

Location

UTHealth Memorial Hermann

Houston, Texas, 77008, United States

Location

Houston Methodist

Houston, Texas, 77030, United States

Location

Intermountain Medical Center

Murray, Utah, 84157, United States

Location

University of Virginia Medical Center

Charlottesville, Virginia, 22908, United States

Location

Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States

Location

Swedish Medical Center

Seattle, Washington, 98107, United States

Location

The Heart Institute at Virginia Mason

Seattle, Washington, 98111, United States

Location

West Virginia University Hospital

Morgantown, West Virginia, 26506, United States

Location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M5N 3M5, Canada

Location

Institut de Cardiologie de Montreal (Montreal Heart Inst.)

Montreal, Quebec, H1T 1C8, Canada

Location

Universitätsklinikum Ulm

Ulm, Bad-wur, 89081, Germany

Location

Klinikum der Johann Wolfgang Goethe-Universität Frankfurt

Frankfurt am Main, Hesse, 60590, Germany

Location

Herz-und Diabetes Zentrum NRW

Bad Oeynhausen, North Rhine-Westphalia, 32545, Germany

Location

Universitätsmedizin der Johannes Gutenberg-Universität Mainz

Mainz, Rhinela, 55131, Germany

Location

Deutsches Herzzentrum München des Freistaates Bayern

München, 80636, Germany

Location

Universitätsklinikum Rostock (AöR)

Rostock, 18057, Germany

Location

Center Inselspital Bern

Bern, Canton of Bern, 3010, Switzerland

Location

Related Publications (2)

• McCarthy PM, Whisenant B, Asgar AW, Ailawadi G, Hermiller J, Williams M, Morse A, Rinaldi M, Grayburn P, Thomas JD, Martin R, Asch FM, Shu Y, Sundareswaran K, Moat N, Kar S. Percutaneous MitraClip Device or Surgical Mitral Valve Repair in Patients With Primary Mitral Regurgitation Who Are Candidates for Surgery: Design and Rationale of the REPAIR MR Trial. J Am Heart Assoc. 2023 Feb 21;12(4):e027504. doi: 10.1161/JAHA.122.027504. Epub 2023 Feb 8.

  PMID: 36752231 DERIVED

• Kaneko T, Hirji S, Zaid S, Lange R, Kempfert J, Conradi L, Hagl C, Borger MA, Taramasso M, Nguyen TC, Ailawadi G, Shah AS, Smith RL, Anselmi A, Romano MA, Ben Ali W, Ramlawi B, Grubb KJ, Robinson NB, Pirelli L, Chu MWA, Andreas M, Obadia JF, Gennari M, Garatti A, Tchetche D, Nazif TM, Bapat VN, Modine T, Denti P, Tang GHL; CUTTING-EDGE Investigators. Mitral Valve Surgery After Transcatheter Edge-to-Edge Repair: Mid-Term Outcomes From the CUTTING-EDGE International Registry. JACC Cardiovasc Interv. 2021 Sep 27;14(18):2010-2021. doi: 10.1016/j.jcin.2021.07.029.

  PMID: 34556275 DERIVED

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Patrick McCarthy, MD

  Northwestern Memorial Hospital

  PRINCIPAL INVESTIGATOR

• Saibal Kar, MD

  Los Robles Regional Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2019
• First Posted: December 13, 2019
• Study Start: July 21, 2020
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2035
• Last Updated: November 12, 2025

Record last verified: 2025-11

Locations

US (63); CH (1); DE (6); CA (4)