Status: Recruiting
COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve Dysfunction
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.
Participants needed: 108
Trial details
Biological sex: AllType: InterventionalSponsor: Edwards LifesciencesUpdated: Mar 6, 2026Locations: 25
Eligibility criteria
Weight ≥ 20 kg (44 lbs.) [+3]
Active infection requiring current antibiotic therapy (if temporary illness, sub... [+13]