MitraClip REPAIR MR Study


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Trial ID: NCT04198870


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.

Official Title

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

Stanford Investigator(s)

John W. MacArthur
John W. MacArthur

Assistant Professor of Cardiothoracic Surgery (Adult Cardiac Surgery)

Christiane Haeffele
Christiane Haeffele

Clinical Associate Professor, Medicine - Cardiovascular Medicine Clinical Assistant Professor, Pediatrics - Cardiology

Kevin M. Alexander, MD, FACC, FHFSA
Kevin M. Alexander, MD, FACC, FHFSA

Assistant Professor of Medicine (Cardiovascular Medicine) at the Stanford University Medical Center

Rahul P Sharma, MBBS, FRACP
Rahul P Sharma, MBBS, FRACP

Clinical Associate Professor, Medicine - Cardiovascular Medicine


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

   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


device: MitraClip™ device implantation

procedure: Mitral Valve Repair Surgery


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Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Tiffany Flores