CTSN PRIMARY Trial (Mitral Valve Regurgitation) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to compare treatment options for mitral valve regurgitation.

What is the Condition Being Studied?

Mitral Valve Regurgitation (MR)

Who Can Participate in the Study?

Adults with mitral valve regurgitation who plan to have it repaired.

For more information about who can join this study, contact the study team at shelly.fincannon@duke.edu.

Age Group

What is Involved?

If you choose to join this study, you will get a random assignment (like a coin flip) to 1 of 2 groups:

  • Group 1: you will have mitral valve surgery, performed in an operating room by a cardiac surgeon
  • Group 2: you will have transcatheter edge-to-edge repair, performed in a cardiac catheterization laboratory by an interventional cardiologist

Participants assigned to both groups will also:

  • Have echocardiograms
  • Complete a six-minute walk test
  • Answer questionnaires

If you do not want to be part of the study that randomly assigns you to treatment, you can participate in a registry. If you join the registry, we will collect data from your medical records related to your treatment for MR so we can learn more about the condition and its treatment outcomes.

Study Details

Full Title
Percutaneous or Surgical Repair In Mitral Prolapse And Regurgitation for >65 Year-olds (PRIMARY)
Principal Investigator
Protocol Number
IRB: PRO00110245
NCT: NCT05051033
Phase N/A
Enrollment Status
Open for Enrollment