COngenital Multicenter trial of Pulmonic vAlve dysfunction Studying the SAPIEN 3 interventIONal THV Post-Approval Study - COMPASSION S3 PAS
Study ID: STU-2021-0535
This is a single arm, prospective, multicenter post-approval study that will be conducted at up to 20 sites in the uS. 150 subjects will be enrolled; a minimum of 40 subjects with a previously implanted surgical valve will be included. Subjects will be assessed at screening/baseline, discharge, 30 days, 1 year and annually thereafter through 5 years. STuDY DeViCeS The following devices will be used: * edwards SaPien 3 THV in 20, 23, 26 and 29 mm valve sizes * edwards Commander Delivery System * edwards eSheath introducer Set or other compatible sheath * edwards Crimper * edwards inflation Device Refer to the current instructions for use (iFu) for descriptions, indications for use, contraindications, system preparation, precautions and warnings. 5 STuDY ouTCoMeS * Device Success, defined as a composite of: o Single THV implanted in the desired location o RV-Pa peak-to-peak gradient [Less Than] 35 mmHg post-implantation o Less than moderate PR by discharge TTe (or earliest evaluable TTe) o Free of explant at 24 hours post-implantation * THV dysfunction at 1, 3, and 5 years, defined as a non-hierarchical composite of: o RVoT reintervention o Moderate or greater total PR via Transthoracic echocardiography (TTe) o Mean RVoT gradient [Greater Than] 40 mmHg via TTe echocardiographic assessments (Total and paravalvular regurgitation, mean and peak RVoT gradient, RVoT end diastolic area, tricuspid regurgitation) at 30 days, and 1, 3, and 5 years * nYHa functional class at 30 days, and 1, 3, and 5 years in addition, adverse events will be summarized.
To 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