Mitral Valve Replacement for Mitral Valve Regurgitation

Recruiting in Palo Alto (17 mi)

+18 other locations

Overseen byRajendra Makkar, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Edwards Lifesciences

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing a new device that replaces a damaged heart valve in patients whose mitral valve is not working properly. The new valve helps the heart pump blood more effectively. The Evalve Mitraclip, a device for percutaneous mitral valve repair, is currently being tested.

Research Team

Rajendra Makkar, MD

Principal Investigator

Cedars-Sinai Medical Center, Los Angeles, CA

Eligibility Criteria

This trial is for individuals with severe, symptomatic mitral valve regurgitation who are at high risk for open-heart surgery but meet specific anatomical criteria. It's not suitable for those considered inoperable or with unsuitable anatomy.

Inclusion Criteria

I have serious symptoms from a leaky heart valve.

My body meets the specific physical requirements.

I am considered high risk for open-heart surgery.

Exclusion Criteria

My body's structure makes me ineligible for the procedure.

My condition cannot be treated with surgery.

Treatment Details

Interventions

Edwards EVOQUE Eos Mitral Valve Replacement System (Mitral Valve Replacement System)

Trial OverviewThe study is testing the Edwards EVOQUE Eos Mitral Valve Replacement System to assess its safety and performance as a treatment option for mitral valve regurgitation.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: TreatmentExperimental Treatment1 Intervention

Treatment with the Edwards EVOQUE Eos mitral valve replacement system