REPAIR-MR (Primary Mitral Regurgitation) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find out if an experimental device is a safe and effective method to repair a leaking mitral valve. The device is called MitraClip, and it is placed in the heart in a less invasive manner that uses a catheter. We want to know how well this device works compared to standard mitral valve repair surgery, which is a more invasive procedure.

What is the Condition Being Studied?

Primary Mitral Regurgitation (MR)

Who Can Participate in the Study?

Adults ages 18+ who:
- Are diagnosed with MR
- Are advised to receive mitral valve repair surgery
- Have an ejection fraction above 30%

For more information about who can join this study, please contact the study team at jennifer.andrews@duke.edu.

Age Group
Adults

What is Involved?

If you choose to join this study, you will:
- Be randomly assigned (like a coin flip) to 1 of 2 groups
-- One group will have standard mitral valve repair surgery
-- The other group will receive the study procedure using the MitraClip device

Neither you nor your study doctor will be able to choose your group assignment.

No matter which group you are assigned to join, we will keep in touch with you for up to 10 years to see how you are doing after your procedure. We will call you on the phone and schedule you for occasional clinic visits.

Study Details

Full Title
Percutaneous MitraClip Device or Surgical Mitral Valve REpair in PAtients with PrImaRy Mitral Regurgitation who are Candidates for Surgery (REPAIR MR)
Principal Investigator
Structural Heart Disease Specialist
Protocol Number
IRB: PRO00107016
NCT: NCT04198870
ClinicalTrials.gov
Enrollment Status
Open for Enrollment
Participate
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698