Edwards EVOQUE System for Tricuspid Valve Disease

Recruiting in Palo Alto (17 mi)

+62 other locations

Dr. James S. Gammie, MD - Lutherville ...

Renowned Surgeon Vinod Thourani, M.D. ...

Philipp Lurz, MD, PhD – Department of ...

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 device called the Edwards EVOQUE system, which replaces a faulty heart valve. It targets patients with severe tricuspid regurgitation, a condition where the heart valve does not close properly. The new valve helps blood flow correctly through the heart, improving its function and reducing symptoms. The EVOQUE system has shown promise in initial studies for treating severe tricuspid regurgitation.

Eligibility Criteria

This trial is for individuals with severe symptoms of tricuspid regurgitation who haven't improved with medical therapy. Candidates should be suitable for a non-surgical valve replacement as determined by their heart care team. People are excluded if they have certain tricuspid valve issues, need urgent heart surgery, are hemodynamically unstable, require advanced treatment for heart failure, or are in another study.

Inclusion Criteria

My condition is considered severe or worse.

I have symptoms from a leaky tricuspid heart valve despite taking medication.

Exclusion Criteria

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

I don't need urgent surgery or any heart surgery in the next year.

My heart failure needs advanced treatment.

My blood pressure and heart rate are stable.

Participant Groups

The TRISCEND II Pivotal Trial is testing the safety and effectiveness of the Edwards EVOQUE system which replaces the tricuspid valve without needing open-heart surgery against Optimal Medical Therapy alone in managing heart valve disease.

4Treatment groups

Experimental Treatment

Active Control

Group I: Single-Arm RegistryExperimental Treatment1 Intervention

Transcatheter tricuspid valve replacement with the Edwards EVOQUE System in conjunction with optimal medical therapy (OMT) in patients with tricuspid regurgitation who are not eligible for randomization

Group II: Edwards EVOQUE System & OMTExperimental Treatment1 Intervention

Transcatheter tricuspid valve replacement with the Edwards EVOQUE System in conjunction with optimal medical therapy (OMT) in patients with tricuspid regurgitation

Group III: Continued Access StudyExperimental Treatment1 Intervention

Provides continued access to transcatheter tricuspid valve replacement with the Edwards EVOQUE System in conjunction with optimal medical therapy (OMT) in patients with tricuspid regurgitation.

Group IV: Optimal Medical Therapy (OMT)Active Control1 Intervention

Optimal medical therapy (OMT) alone in patients with tricuspid regurgitation