clinical trial · NCT04860765
COMPASSION S3 Post-Approval Study
Edwards Lifesciences·—·active not recruiting·n = 150
Complex Congenital Heart DefectDysfunctional RVOT ConduitPulmonary Valve InsufficiencyPulmonary Valve DegenerationPulmonary Valve; ObstructionSAPIEN 3 THV
brief summary
This study will monitor device performance and outcomes of the SAPIEN 3 Transcatheter Heart Valve (THV) System in subjects with a dysfunctional right ventricular outflow tract (RVOT) conduit or previously implanted surgical valve in the pulmonic position with a clinical indication for intervention.
started
Apr 13, 2021
primary completion
Aug 1, 2030
completion
Aug 1, 2030
last updated
Feb 3, 2026
detailed description
This is a single arm, prospective, multicenter post-approval study.
official title
Congenital Multicenter Trial of Pulmonic Valve Dysfunction Studying the SAPIEN 3 Interventional THV Post-Approval Study
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol