REPAIR-MR (Primary Mitral Regurgitation)

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.

Who Can Participate?

Eligibility

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 Range

18-110

Sex/Genders

Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No

What is Involved?

Description

If you choose to join this study, you will get a random assignment (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.

Locations

Duke University Hospital

Visit Timing

Weekdays

Compensation

No

Spanish Materials Available

Yes

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)

Study Website

Study Website

Principal Investigator

Andrew
Wang

Protocol Number

PRO00107016

NCT ID

NCT04198870

Enrollment Status

Open to Enrollment
ClinicalTrials.gov