Trials / Active Not Recruiting
Active Not RecruitingNCT04860765
COMPASSION S3 Post-Approval Study
Congenital Multicenter Trial of Pulmonic Valve Dysfunction Studying the SAPIEN 3 Interventional THV Post-Approval Study
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 150 (actual)
- Sponsor
- Edwards Lifesciences · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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.
Conditions
- Complex Congenital Heart Defect
- Dysfunctional RVOT Conduit
- Pulmonary Valve Insufficiency
- Pulmonary Valve Degeneration
- Pulmonary Valve; Obstruction
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | SAPIEN 3 THV | SAPIEN 3 THV in the pulmonic position |
Timeline
- Start date
- 2021-04-13
- Primary completion
- 2030-08-01
- Completion
- 2030-08-01
- First posted
- 2021-04-27
- Last updated
- 2026-02-03
Locations
19 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT04860765. Inclusion in this directory is not an endorsement.