Transcatheter Tricuspid Valve Replacement for Tricuspid Regurgitation

Recruiting in Palo Alto (17 mi)

+21 other locations

Overseen BySusheel Kodali, 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 heart valve replacement device for patients with tricuspid valve problems. The device replaces the damaged valve to improve heart function.

Eligibility Criteria

This trial is for people with a heart condition called tricuspid regurgitation who still have symptoms despite medication or have been hospitalized for heart failure. They must be considered suitable for a non-surgical valve replacement by their medical team, and not in need of urgent surgery or other cardiac procedures within the next year.

Inclusion Criteria

I still have symptoms despite treatment, or I was hospitalized for heart failure.

Exclusion Criteria

My heart's tricuspid valve has a physical issue preventing certain treatments.

My blood pressure and heart rate are stable.

I do not need any urgent surgery or have any planned heart surgery in the next year.

My heart failure needs advanced treatment.

Participant Groups

The TRISCEND study is testing the safety and effectiveness of a new procedure called Transcatheter Tricuspid Valve Replacement using the Edwards EVOQUE system. It's done without open-heart surgery to see if it can help patients with tricuspid valve issues.

1Treatment groups

Experimental Treatment

Group I: TreatmentExperimental Treatment1 Intervention

Treatment with the Edwards EVOQUE Tricuspid Valve Replacement System