APOLLO Study for Mitral Valve Replacement - Clinical Trial
What is the Purpose of this Study?
We are doing this study to learn more about the safety and effectiveness of the Medtronic Intrepid Transcatheter Mitral Valve Replacement System.
Heart disease called severe 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?
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