CTSN PRIMARY Trial (Mitral Valve Regurgitation)

Purpose of this Study

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

Who Can Participate?

Eligibility

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 Range

60-110

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:
  • 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.

Locations

Duke University Hospital

Visit Timing

Weekdays

Compensation

No

Spanish Materials Available

No

Study Details

Full Title

Percutaneous or Surgical Repair In Mitral Prolapse And Regurgitation for >65 Year-olds (PRIMARY)

Principal Investigator

Donald
Glower

Protocol Number

PRO00110245

NCT ID

NCT05051033

Phase

N/A

Enrollment Status

Open to Enrollment
ClinicalTrials.gov