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

  • STATUS
    Recruiting
  • End date
    Feb 11, 2032
  • participants needed
    500
  • sponsor
    Abbott Medical Devices
Updated on 11 October 2022
Investigator
Diana Posa Podean
Primary Contact
Ottawa Heart Institute (4.1 mi away) Contact
+53 other location
mitral valve repair

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 surgeon on the local site heart team.

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

Eligibility

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
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