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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional




Official Title: COngenital Multicenter Trial of Pulmonic vAlve Dysfunction Studying the SAPIEN 3 interventIONal THV

Brief Summary: The purpose of this study is to evaluate the hypothesis that valve dysfunction of the Edwards Lifesciences SAPIEN 3 Transcatheter Heart Valve (THV) System is within the performance goal of 25% in subjects with a dysfunctional right ventricular outflow tract (RVOT) conduit with a clinical indication for intervention.