Clinical Trial

COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve Dysfunction

Recruiting
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Summary
This study will demonstrate the safety and effectiveness of the Edwards Lifesciences SAPIEN 3/SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve (THV) Systems in subjects with a dysfunctional right ventricular outflow tract (RVOT) conduit or previously implanted valve in the pulmonic position with a clinical indication for intervention.
Protocol Amendment History 23 amendments
This ClinicalTrials.gov record has been amended 23 times since 2016-04-15; most recent amendment 2026-07-21.
Status change: Active, Not Recruiting → Recruiting 2019-04-23
Status change: Recruiting → Active, Not Recruiting 2018-09-05
Status change: Not Yet Recruiting → Recruiting 2016-06-14
Trial Details
NCT Number NCT02744677
Lead Sponsor Edwards Lifesciences
Conditions Complex Congenital Heart Defect, Dysfunctional RVOT Conduit, Pulmonary Valve Insufficiency, Pulmonary Valve Degeneration
Enrollment 108 participants
Start Date 2016-07-05
Primary Completion 2026-12 (estimated)
Study Completion 2031-06 (estimated)
Updated on ClinicalTrials.gov 2026-07-23