APOLLO - Mitral Valve Regurgitation - 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.
What is the Condition Being Studied?
Mitral Valve Regurgitation
Who Can Participate in the Study?
Adults who:
- Are good candidates for bioprosthetic mitral valve replacement
- Agree to return for all required post-procecure follow-up visits
- Don't need urgent surgery
- Agree to blood transfusion as needed
- Don't have severe COPD
Age Group
Adults
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
- Get a random assignment (like a coin flip) to either have Transcatheter Mitral Valve Replacement (TMVR) with the Intrepid system OR conventional mitral valve surgery
Both of the study's valve replacement procedures will require a 4-5 day hospital stay.
Study Details
Full Title
Transcatheter Mitral Valve Replacement with the Medtronic Intrepid TMVR System in patients with severe symptomatic mitral regurgitation- APOLLO
Principal Investigator
Structural Heart Disease Specialist
Protocol Number
IRB:
PRO00087240
NCT:
NCT03242642
Phase
Phase
N/A
ClinicalTrials.gov
View on ClinicalTrials.gov
Enrollment Status
Open for Enrollment