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.
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?
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.
- 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 ACCRUAL