Percutaneous MitraClipTM Device or Surgical Mitral Valve REpair in PAtients with PrImaRy MItral Regurgitation who are Candidates for Surgery (REPAIR-MR)

Brief description of study

REPAIR-MR is a prospective, multicenter, randomized, controlled, clinical trial of the MitraClip™ device in subjects with severe primary MR 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. The trial will randomize approximately 500 eligible subjects at up to 60 sites, in a 1:1 ratio to receive either: • The MitraClip™ device (Device Group): Subjects will undergo implantation with the MitraClip™ device, or • Mitral Valve Repair Surgery (Control Group): Subjects will undergo mitral valve repair surgery

Clinical Study Identifier: s20-00289

ClinicalTrials.gov Identifier: NCT04198870

Principal Investigator: Mathew R. Williams.

Other Investigators: Tara Ann Collins, Alan F Vainrib, Muhamed Saric, Daniel G Bamira, Cezar S Staniloae, Aubrey C Galloway, Didier F. Loulmet.

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