Purpose of this Study
If you choose to join the study you will:
- Be in the study for 5 years
- Have 8 study visits that will last 1-3 hours each and include physical exams, blood and urine tests, walk tests, imaging and questionnaires about how you're feeling
- Be randomized (like the flip of a coin) to receive either:
--- Transcatheter Mitral Valve Replacement (TMVR) with the Intrepid system
OR
--- Conventional mitral valve surgery
Both of these are inpatient procedures and require a 4-5 day hospital stay
- Be in the study for 5 years
- Have 8 study visits that will last 1-3 hours each and include physical exams, blood and urine tests, walk tests, imaging and questionnaires about how you're feeling
- Be randomized (like the flip of a coin) to receive either:
--- Transcatheter Mitral Valve Replacement (TMVR) with the Intrepid system
OR
--- Conventional mitral valve surgery
Both of these are inpatient procedures and require a 4-5 day hospital stay
Who Can Participate?
Eligibility
Adults who:
- Are candidates for bioprosthetic mitral valve replacement
- Agree to return for all required post-procedure follow up visits
- Don't need urgent surgery
- Agree to blood transfusion as needed
- Have not had a stroke or TIA within 90 days of enrollment
- Don't have severe COPD
- Are candidates for bioprosthetic mitral valve replacement
- Agree to return for all required post-procedure follow up visits
- Don't need urgent surgery
- Agree to blood transfusion as needed
- Have not had a stroke or TIA within 90 days of enrollment
- Don't have severe COPD
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?
We are doing this study to learn more about the safety and effectiveness of the Medtronic Intrepid Transcatheter Mitral Valve Replacement System.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
Transcatheter Mitral Valve Replacement with the Medtronic Intrepid TMVR System in patients with severe symptomatic mitral regurgitation- APOLLO
Principal Investigator
John
Harrison
Protocol Number
PRO00087240
NCT ID
NCT03242642
Phase
N/A
Enrollment Status
OPEN TO ACCRUAL