Study ID: Repair MR
Percutaneous MitraClip device or surgical mitral valve repair in patients with primary mitral regurgitation who are candidates for surgery (REPAIR MR)
This randomized study is comparing a device called a MitraClip™ to surgically repair severe mitral valve regurgitation, a condition in which blood flow through the mitral valve moves in the incorrect direction during part of the cardiac cycle.
The MitraClip is a device that is guided through a leg vein to the heart and implanted on the mitral valve to help it close more completely, thus helping to restore normal blood flow through the heart.
Participants are randomized into two study groups. One receives treatment with the MitraClip. The other group receives surgical repair of the mitral valve.
The objective of this randomized controlled trial is to compare the clinical outcome of MitraClip™ device vs. 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.
The primary outcomes being measured in this study include:
- All-cause mortality, stroke, cardiac hospitalization, or acute kidney injury requiring renal replacement therapy at two years
- Proportion of subjects with moderate or less MR (≤2+), without mitral valve replacement, and without recurrent mitral valve intervention (surgical or percutaneous) at two years
- Must have been diagnosed with severe primary mitral regurgitation
- Must be at moderate surgical risk
- Mitral valve has been determined to be suitable for correction by repair
- Other inclusion/exclusion criteria apply