Congenital Multicenter Trial of Pulmonic Valve Dysfunction Studying the SAPIEN 3 Interventional THV Post-Approval Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 150
- Locations
- 19
- Primary Endpoint
- Device Success
Study Overview
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.
Detailed Description
This is a single arm, prospective, multicenter post-approval study.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Dysfunctional RVOT conduit or previously implanted surgical valve
- •RVOT/PV with ≥ moderate regurgitation and/or a mean RVOT/PV gradient of ≥ 35 mmHg
Exclusion Criteria
- •Inability to tolerate an anticoagulation/antiplatelet regimen
- •Active bacterial endocarditis or other active infections
Arms & Interventions
TPVR
Subjects with a dysfunctional RVOT conduit or previously implanted surgical valve in the pulmonic position will undergo transcatheter pulmonary valve replacement (TPVR).
Intervention: SAPIEN 3 THV (Device)
Outcomes
Primary Outcomes
Device Success
Time Frame: Discharge, expected to be within 1-5 days post-procedure
Defined as a composite of: * Single THV implanted in the desired location * Right ventricle to pulmonary artery peak-to-peak gradient \< 35 mmHg post-implantation * Less than moderate PR by discharge TTE * Free of explant at 24 hours post-implantation
Secondary Outcomes
No secondary outcomes reported