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Comparing MitraClip device to surgical repair for severe mitral valve regurgitation

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

Not applicable Interventional Abbott Medical Devices · NCT04198870

This study is testing whether the MitraClip device works better than traditional surgery for people with severe mitral valve regurgitation who are at moderate risk for surgery.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment500 (estimated)
Ages18 Years and up
SexAll
SponsorAbbott Medical Devices Industry-sponsored
Locations85 sites (Birmingham, Alabama and 84 other locations)
Trial IDNCT04198870 on ClinicalTrials.gov

What this trial studies

This randomized controlled trial aims to evaluate the clinical outcomes of the MitraClip™ device compared to traditional surgical repair in patients with severe primary mitral valve regurgitation who are at moderate surgical risk. Participants will be assessed for their suitability for either intervention based on their mitral valve anatomy and overall health status. The study will involve a team of cardiac specialists to ensure appropriate patient selection and intervention. The primary focus is on achieving significant improvement in mitral regurgitation severity and patient symptoms.

Who should consider this trial

Good fit: Ideal candidates for this study are patients aged 75 or older with severe primary mitral valve regurgitation who are symptomatic or have specific heart function criteria.

Not a fit: Patients who are not candidates for mitral valve surgery or those with low surgical risk may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a less invasive treatment option for patients with severe mitral valve regurgitation, potentially leading to better outcomes and quicker recovery times.

How similar studies have performed: Previous studies have shown promising results with the MitraClip device, indicating its potential effectiveness in treating mitral valve regurgitation.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. 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.
2. 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
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 at the time of EC review. If younger than 75 years, then the subject should have:

   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
5. Subject provides written informed consent
6. Subject is ≥ 18 years of age

Exclusion Criteria:

1. Subject is currently participating in another clinical investigation
2. 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.
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 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
10. Surgical procedure performed in the past 30 days
11. Femoral vein cannot accommodate a 24 F catheter or presence of IVC filter would interfere 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

Where this trial is running

Birmingham, Alabama and 84 other locations

+35 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Mitral Valve RegurgitationMitraClip
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.