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

  • End date
    Feb 11, 2032
  • participants needed
  • sponsor
    Abbott Medical Devices
Updated on 11 October 2022
mitral valve repair


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.

Condition Mitral Valve Regurgitation
Treatment MitraClip™ device implantation, Mitral Valve Repair Surgery
Clinical Study IdentifierNCT04198870
SponsorAbbott Medical Devices
Last Modified on11 October 2022


Yes No Not Sure

Inclusion Criteria

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 pressure systolic pressure > 50 mmHg, or LVESD > 40 mm
Subject is at moderate surgical risk defined as being at least 75 years of age, OR if younger than 75 years, then has: (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
Subject provides written informed consent
Subject is ≥ 18 years of age

Exclusion Criteria

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 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 MitraClipTM 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
Subjects who are pregnant or planning to be pregnant
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact


Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note