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MitraClip REPAIR MR Study
Recruiting
I'm InterestedTrial ID: NCT04198870
Purpose
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
Assistant Professor of Cardiothoracic Surgery (Adult Cardiac Surgery)
Christiane Haeffele
Clinical Associate Professor, Medicine - Cardiovascular Medicine Clinical Assistant Professor, Pediatrics - Cardiology
Kevin M. Alexander, MD, FACC, FHFSA
Assistant Professor of Medicine (Cardiovascular Medicine) at the Stanford University Medical Center
Rahul P Sharma, MBBS, FRACP
Clinical Associate Professor, Medicine - Cardiovascular Medicine
Eligibility
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
Intervention(s):
device: MitraClip™ device implantation
procedure: Mitral Valve Repair Surgery
Recruiting
I'm InterestedContact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Tiffany Flores
650-725-8718