Transcatheter Valve Repair for Tricuspid Regurgitation
(CLASP TR EFS Trial)

Recruiting in Palo Alto (17 mi)

+14 other locations

Overseen bySusheel K. 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?

Early feasibility study to assess the safety and performance of the Edwards PASCAL Transcatheter Valve Repair System in tricuspid regurgitation

Eligibility Criteria

This trial is for individuals with severe tricuspid regurgitation (a heart valve disease) who still have symptoms despite medication. Candidates should be deemed appropriate for a non-surgical valve repair by their medical team. Those with unsuitable anatomy, conditions affecting study participation or scientific integrity, or previous tricuspid repairs are excluded.

Inclusion Criteria

I have severe valve issues in my heart.

My heart team has approved me for a specific heart valve repair procedure.

My symptoms persist despite taking medication.

Exclusion Criteria

Co-morbid condition(s) that, in the opinion of the investigator, could limit the patient's ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study

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

I have had surgery on my tricuspid heart valve.

Treatment Details

Interventions

Edwards PASCAL Transcatheter Valve Repair System (Transcatheter Valve Repair System)
Transcatheter Tricuspid Valve Repair (Transcatheter Valve Repair System)

Trial OverviewThe Edwards PASCAL Transcatheter Valve Repair System is being tested in this early feasibility study to see if it's safe and works well for repairing the tricuspid valve in the heart without needing open-heart surgery.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: TreatmentExperimental Treatment1 Intervention

Treatment with the Edwards PASCAL Transcatheter Valve Repair System