Percutaneous MitraClipTM Device or Surgical Mitral Valve REpair in PAtients with PrImaRy Mitral Regurgitation who are Candidates for Surgery (REPAIR MR)
MitraClip REPAIR MR Study in Patients with Primary Mitral Regurgitation
Sponsor: Abbott Medical Devices
Enrolling: Male and Female Patients
Clinic Visits: 8
IRB Number: AAAT3404
U.S. Govt. ID: NCT04198870
Contact: Kate Dalton: 347-514-3366 /
Additional Study Information: This is a randomized controlled trial (RCT) that will 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. In this trial, each subject will be followed until their 10-year visit. Clinical Investigation visits will occur at Screening (for determination of eligibility), Baseline (after confirmation of eligibility), Index Procedure, Discharge, 30 days, 6 months, 1 year, 18 months, and annually thereafter from 2 to 10 years. A phone-only visit will be conducted for 6 months, 18 months, and years 6, 7, and 9 and an in-office visit will be conducted for all other time points (30 days, annually at 1-5 years, and at 8 and 10 years).
Susheel Kodali, MD
Do You Qualify?
Are you 18 years or older? Yes No
Are you willing to return to Columbia University Medical Center for all research required follow up visits? Yes No
Have you had a surgical procedure performed in last 30 days? Yes No
Are you diagnosed with Renal Insufficiency requiring dialysis? Yes No
You may be eligible for this study

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For more information, please contact:
Kate Dalton