AzTrials
AzTrials

Mitral Valve RegurgitationNCT04198870

MitraClip REPAIR MR Study

A study testing MitraClip™ device implantation and Mitral Valve Repair Surgery in people with Mitral Valve Regurgitation, run by Abbott Medical Devices at 74 sites in 4 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Mitral Valve Regurgitation
What is being tested?
MitraClip™ device implantation and Mitral Valve Repair Surgery
Could I receive a placebo?
No, everyone receives an active treatment
How many people
500 participants
Where
74 sitesin 4 countries
Study dates
21 Jul 2020to Dec 2035
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 19Show fewer
  • 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
  • Systolic anterior motion of the mitral valve
  • Hypertrophic cardiomyopathy
  • Renal insufficiency requiring dialysis
  • Active infections requiring current antibiotic therapy

Trial locations and contacts

74 sites in 4 countries.

74 sites in 4 countries

United States63 sites

  • Albany Medical Center

    Albany, New York, 12208

  • University of Michigan Medical Center

    Ann Arbor, Michigan, 48104

  • Mission Health & Hospitals

    Asheville, North Carolina, 28801

  • Piedmont Heart Institute

    Atlanta, Georgia, 30309

  • Ascension Texas Cardiovascular Research

    Austin, Texas, 78705

  • South Shore University Hospital

    Bay Shore, New York, 11706

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

    Birmingham, Alabama, 35249

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Cooper University Hospital

    Camden, New Jersey, 08103

  • Carolinas Medical Center

    Charlotte, North Carolina, 28203

  • University of Virginia Medical Center

    Charlottesville, Virginia, 22908

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611

  • Christ Hospital

    Cincinnati, Ohio, 45219

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

  • Mt. Carmel East

    Columbus, Ohio, 43213

  • Saint Joseph Hospital

    Denver, Colorado, 80218

  • Henry Ford Health

    Detroit, Michigan, 48202

  • Duke University Medical Center

    Durham, North Carolina, 27705

  • Pinnacle Health Cardiovascular Institute, Inc.

    Harrisburg, Pennsylvania, 17105

  • HCA Houston Healthcare Medical Center

    Houston, Texas, 77004

  • UTHealth Memorial Hermann

    Houston, Texas, 77008

  • Houston Methodist

    Houston, Texas, 77030

  • Ascension St. Vincent

    Indianapolis, Indiana, 46240

  • Baptist Medical Center

    Jacksonville, Florida, 32207

  • Kansas University Medical Center

    Kansas City, Kansas, 66160

  • Scripps Health

    La Jolla, California, 92037

  • Abbott Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Cardiology Associates of Mobile, Inc.

    Mobile, Alabama, 36608

  • West Virginia University Hospital

    Morgantown, West Virginia, 26506

  • Morristown Medical Center

    Morristown, New Jersey, 07962

  • Intermountain Medical Center

    Murray, Utah, 84157

  • NCH Healthcare System

    Naples, Florida, 34102

  • TriStar Centennial Medical Center

    Nashville, Tennessee, 37203

  • Ascension Saint Thomas

    Nashville, Tennessee, 37205

  • Vanderbilt Heart & Vascular Institute

    Nashville, Tennessee, 37232

  • Jersey Shore University Medical Center

    Neptune City, New Jersey, 07753

  • Yale New Haven Hospital

    New Haven, Connecticut, 06510

  • NYU Langone Health

    New York, New York, 10016

  • New York-Presbyterian/Columbia University Medical Center

    New York, New York, 10032

  • Sentara Norfolk General Hospital

    Norfolk, Virginia, 23507

  • Integris Baptist Medical Center

    Oklahoma City, Oklahoma, 73112

  • Banner-University Medical Center Phoenix

    Phoenix, Arizona, 85006

  • St. Josephs Hospital and Medical Center

    Phoenix, Arizona, 85013

  • Arizona Cardiovascular Research Center

    Phoenix, Arizona, 85016

  • Allegheny General Hospital - ASRI

    Pittsburgh, Pennsylvania, 15212

  • UPMC

    Pittsburgh, Pennsylvania, 15213

  • Rochester Regional Health

    Rochester, New York, 14617

  • St. Francis Hospital

    Roslyn, New York, 11576

  • Beaumont Hospital, Royal Oak

    Royal Oak, Michigan, 48073

  • Sutter Medical Center, Sacramento

    Sacramento, California, 95816

  • University of California - Davis Medical Center

    Sacramento, California, 95817

  • Mercy General Hospital

    Sacramento, California, 95819

  • University of California at San Francisco

    San Francisco, California, 94143

  • Swedish Medical Center

    Seattle, Washington, 98107

  • The Heart Institute at Virginia Mason

    Seattle, Washington, 98111

  • Prairie Education & Research Cooperative

    Springfield, Illinois, 62701

  • Stanford University Medical Center

    Stanford, California, 94305

  • Los Robles Regional Medical Center

    Thousand Oaks, California, 91360

  • Tucson Medical Center

    Tucson, Arizona, 85712

  • Via Christi Regional Medical Center - St. Francis Campus

    Wichita, Kansas, 67214

  • Cardiovascular Research Institute of Kansas

    Wichita, Kansas, 67226

  • Lankenau Institute for Medical Research

    Wynnewood, Pennsylvania, 19096

Other trials in United States

Germany6 sites

  • Herz-und Diabetes Zentrum NRW

    Bad Oeynhausen, North Rhine-Westphalia, 32545

  • Klinikum der Johann Wolfgang Goethe-Universität Frankfurt

    Frankfurt am Main, Hesse, 60590

  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz

    Mainz, Rhinela, 55131

  • Deutsches Herzzentrum München des Freistaates Bayern

    München, 80636

  • Universitätsklinikum Rostock (AöR)

    Rostock, 18057

  • Universitätsklinikum Ulm

    Ulm, Bad-wur, 89081

Other trials in Germany

Canada4 sites

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

    Montreal, Quebec, H1T 1C8

  • St. Michael's Hospital

    Toronto, Ontario, M5B 1W8

  • Toronto General Hospital

    Toronto, Ontario, M5G 2C4

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M5N 3M5

Other trials in Canada

Switzerland1 site

  • Center Inselspital Bern

    Bern, Canton of Bern, 3010

Other trials in Switzerland

About this study

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

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.

Being tested
MitraClip™ device implantation, Mitral Valve Repair Surgery
Keywords
MitraClip
Medical subject headings
Mitral Valve Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MitraClip™ device implantationDevice

    Transcatheter repair of the mitral valve using MitraClip™ device

  • Mitral Valve Repair SurgeryProcedure or surgery

    Surgical repair of the mitral valve

Study groups in NCT04198870
Study groupRoleWhat they receive
Control ArmOtherMitral Valve Repair Surgery
Receives: Procedure: Mitral Valve Repair Surgery
Device ArmExperimentalMitraClip™ device implantation
Receives: Device: MitraClip™ device implantation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 2 Years

  2. 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

    Measured: 2 Years

Secondary outcomes (5)

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

    The proportion of subjects with MR ≤ mild at 30 days post index procedure among survivors will be compared between the Device and Control groups

    Measured: 30 Days

  2. Number of days at hospital from index procedure to home discharge

    Hospital length of stay from index procedure to home discharge (days) in Device group compared to the Control group

    Measured: At Discharge (≤ 14 days following index procedure)

  3. Proportion of subjects discharged to home post index hospitalization

    The proportion of subjects who are discharged to home post index hospitalization will be compared between the Device and Control groups

    Measured: At Discharge (≤ 14 days following index procedure)

  4. 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.

    The proportion of subjects who have at least a 10 point improvement in KCCQ at 2 years post index procedure from baseline among survivors will be compared between the Device and Control groups for non-inferiority.

    The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered questionnaire used for quantifying patient's health status including the symptoms (frequency and burden), physical and social limitations, and quality of life impact due to the heart failure syndrome. Validity, reproducibility, responsiveness and interpretability of the scores have been independently established for each of these health status domains, and overall summary scores are reported in a range of 0-100, in which higher scores reflect better health status.

    Measured: 2 Years

  5. Severe symptomatic mitral stenosis at 1 year

    The proportion of subjects who have severe symptomatic mitral stenosis at 1 year post index procedure will be compared between the Device and Control groups

    Measured: 1 Year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Dec 2019
  2. Study start21 Jul 2020
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2035 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04198870
Sponsor's protocol ID
ABT-CIP-10304
Status last verified
Nov 2025
First submitted
11 Dec 2019
Last updated
15 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

Publications

  • 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.

    PubMed 36752231

  • 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.

    PubMed 34556275

Questions about this trial

What is this clinical trial studying?

A study testing MitraClip™ device implantation and Mitral Valve Repair Surgery in people with Mitral Valve Regurgitation, run by Abbott Medical Devices at 74 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 74 sites in United States, Germany, Canada, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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) (time frame: 2 Years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04198870, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in