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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 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 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

- 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  

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
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698