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.
Who Can Participate?
Eligibility
Adults who:<ul>
<li>Are good candidates for bioprosthetic mitral valve replacement</li>
<li>Agree to return for all required post-procecure follow-up visits</li>
<li>Don't need urgent surgery</li>
<li>Agree to blood transfusion as needed</li>
<li>Don't have severe COPD</li></ul>
<li>Are good candidates for bioprosthetic mitral valve replacement</li>
<li>Agree to return for all required post-procecure follow-up visits</li>
<li>Don't need urgent surgery</li>
<li>Agree to blood transfusion as needed</li>
<li>Don't have severe COPD</li></ul>
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?
If you choose to join the study you will:<ul>
<li>Be in the study for 5 years</li>
<li>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</li>
<li>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</li></ul>
Both of the study's valve replacement procedures will require a 4-5 day hospital stay.
<li>Be in the study for 5 years</li>
<li>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</li>
<li>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</li></ul>
Both of the study's valve replacement procedures will require a 4-5 day hospital stay.
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 Enrollment