REPAIR-MR Mitral Valve Repair Study
Protocol: STUDY00004788
Full Title
Percutaneous MitraClipTM Device or Surgical Mitral Valve REpair in PAtients with PrImaRy MItral Regurgitation who are Candidates for Surgery (REPAIR-MR)
Description
This study enrolls people who have Mitral Regurgitation (MR) who will be having mitral valve surgery. The purpose of this study is to learn about the effectiveness of the MitraClip™ system for treating patients who are candidates for Mitral Valve (MV) repair surgery. We will compare the MitraClip™ system to MV repair surgery which is the current standard of care for this condition.

In this study, you will be randomly selected (lkike the flip of a coin) to have the usual standard of care MV repair surgery or to have the MitraClip Device used in your surgery. You will have 8 in-person and 5 phone follow ups over 10 years after your surgery. Study takes place at Gates Vascular Institute in Buffalo, NY.

Technical Description

The objective of this randomized controlled trial (RCT) is to compare the clinical outcome of MitraClip??? device versus open 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.
Compensation: No
Eligibility
-Adults age 75+ (OR if younger than 75 years, then has other conditions that make them eligible for the study).
-Diagnosed with severe mitral regurgitation.
-Your care team has confirmed that your mitral valve anatomy is suitable for percutaneous repair with the MitraClip device.
Age Group: Adults
Principal Investigator: VIJAY IYER
ClinicalTrials.gov: Open Study
Contact(s)
ROBIN STEIN
rmstein3@buffalo.edu
+1 716-888-4859
Want to Learn More?
Let us know how the study team can reach you. If you do not hear back within 2 business days, reach out to the study team directly at the contact information above or email ctsiresearch@buffalo.edu and someone will assist you.