APOLLO - Mitral Valve Regurgitation - Clinical Trial
What is the 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
--- Conventional mitral valve surgery
Both of these are inpatient procedures and require a 4-5 day hospital stay
Mitral Valve Regurgitation
Who Can Participate in the Study?
- 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
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.