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.
- 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?
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.
- 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.
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
Principal Investigator
Andrew
Wang
Protocol Number
PRO00107016
NCT ID
NCT04198870
Enrollment Status
OPEN TO ACCRUAL