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.
Detailed Summary: The purpose of this study is 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.
Sponsor: Edwards Lifesciences
Current Primary Outcome: THV dysfunction, defined as a non-hierarchical composite of: RVOT reintervention, Moderate or greater total pulmonary regurgitation (PR) via Transthoracic Echocardiography (TTE), Mean RVOT gradient < 40 mmHg via TTE [ Time Frame: 1 year ]
Original Primary Outcome: THV dysfunction, defined as a non-hierarchical composite of: RVOT reintervention, Moderate or greater total pulmonary regurgitation (PR) via Transthoracic Echocardiography (TTE), Mean RVOT gradient > 40 mmHg via TTE [ Time Frame: 1 year ]
Current Secondary Outcome: Device Success [ Time Frame: Immediately post-procedure ]
Original Secondary Outcome:
- Device Success [ Time Frame: Immediately post-procedure ]Defined as a composite of: 1) Single THV implanted in the desired location, 2) RV-PA peak-to-peak gradient < 35 mmHg post-implantation, 3) Less than moderate PR by discharge TTE (or earliest evaluable TTE), 4) Free of explant at 24 hours post-implantation.
- Mean RVOT gradient via TTE [ Time Frame: 6 months ]
- Paravalvular and total PR via TTE [ Time Frame: 6 months ]
- RVOT reintervention [ Time Frame: 6 months ]
- Coronary artery compression requiring intervention [ Time Frame: Post-implantation through 30 days ]
- Major Vascular Complications [ Time Frame: 30 days ]
- Life-threatening or disabling bleeding [ Time Frame: 30 days ]
- THV frame fracture [ Time Frame: 6 months ]
- Device-related endocarditis [ Time Frame: 1 year ]
- Death (all-cause, procedural and device-related) [ Time Frame: 1 year ]
Information By: Edwards Lifesciences
Dates:
Date Received: April 12, 2016
Date Started: April 2016
Date Completion: December 2022
Last Updated: April 11, 2017
Last Verified: April 2017