COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve Dysfunction
Status:
Recruiting
Trial end date:
2031-06-01
Target enrollment:
Participant gender:
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.