COMPASSION S3 Post-Approval Study

Recruiting in Palo Alto (17 mi)

+19 other locations

Age: Any Age

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 study will monitor device performance and outcomes of the SAPIEN 3 Transcatheter Heart Valve (THV) System in subjects with a dysfunctional right ventricular outflow tract (RVOT) conduit or previously implanted surgical valve in the pulmonic position with a clinical indication for intervention.

Eligibility Criteria

Inclusion Criteria

Dysfunctional RVOT conduit or previously implanted surgical valve

RVOT/PV with ≥ moderate regurgitation and/or a mean RVOT/PV gradient of ≥ 35 mmHg

Treatment Details

Interventions

• SAPIEN 3 THV (Transcatheter Heart Valve)

Participant Groups

Group I: TPVR Experimental Treatment 1 Intervention

Subjects with a dysfunctional RVOT conduit or previously implanted surgical valve in the pulmonic position will undergo transcatheter pulmonary valve replacement (TPVR).

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Pittsburgh Medical Center Pittsburgh, PA

Columbia University Irving Medical Center/ New York Presbytarian Hospital New York, NY

Children's Hospital of Colorado Aurora, CO

Nationwide Children's Hospital Columbus, OH

More Trial Locations

Who Is Running the Clinical Trial?

Edwards Lifesciences Lead Sponsor

References