Study of the SAPIEN 3 and SAPIEN 3 Ultra RESILIA Transcatheter Heart Valves for Treating Pulmonary Valve Dysfunction and Right Ventricular Outflow Tract Problems

What this Trial Is About

This trial evaluates the safety and effectiveness of the Edwards Lifesciences SAPIEN 3 and SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve THV Systems in people with a dysfunctional right ventricular outflow tract RVOT conduit or a previously implanted valve in the pulmonic position who need medical intervention. The study focuses on those with clinical indications for treatment to address pulmonary valve dysfunction and related heart conditions. Participants will receive transcatheter pulmonary valve replacement TPVR using either the SAPIEN 3 or SAPIEN 3 Ultra RESILIA THV devices. The study includes subjects with dysfunctional RVOT conduits, previously implanted surgical valves, or previously implanted transcatheter valves in the pulmonic position. Each participant undergoes TPVR as the main intervention. Throughout the study, participants will be monitored for outcomes such as valve dysfunction at one year, device success shortly after discharge, heart function measures at six months, and various safety events including vascular complications and bleeding within 30 days. The study involves follow-up visits for up to one year to assess heart valve performance, complications, and overall health status. The total study period extends until June 2031, with primary completion planned by December 2026.

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