APOLLO - Mitral Valve Regurgitation

APOLLO - Mitral Valve Regurgitation

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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:
  • 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 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?

Description

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.

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
ClinicalTrials.gov