Compassion S3

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

Compassion S3 [NCT02744677]

Description: 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.

Device: SAPIEN 3 THV

Primary Investigator: Kereiakes
Other Investigator(s): Leventhal

Drug/Device Information
To demonstrate the safety and effectiveness of the Edwards Lifesciences SAPIEN 3 THV System in subjects with a dysfunctional RVOT conduit with a clinical indication for intervention
Edwards SAPIEN 3 THV, Edwards Commander Delivery System and accessories will be used in this study (SAPIEN 3 System)
Nonrandomized, single arm, prospective study
Edwards Lifesciences LLC