Trials / Recruiting
RecruitingNCT02744677
COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve Dysfunction
COngenital Multicenter Trial of Pulmonic vAlve Dysfunction Studying the SAPIEN 3 interventIONal THV
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 108 (estimated)
- Sponsor
- Edwards Lifesciences · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
This study will demonstrate the safety and effectiveness of the Edwards Lifesciences SAPIEN 3/SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve (THV) Systems in subjects with a dysfunctional right ventricular outflow tract (RVOT) conduit or previously implanted valve in the pulmonic position with a clinical indication for intervention.
Conditions
- Complex Congenital Heart Defect
- Dysfunctional RVOT Conduit
- Pulmonary Valve Insufficiency
- Pulmonary Valve Degeneration
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | SAPIEN 3/SAPIEN 3 Ultra RESILIA THV | SAPIEN 3/SAPIEN 3 Ultra RESILIA THV in the pulmonic position |
| DEVICE | SAPIEN 3 THV | SAPIEN 3 THV in the pulmonic position |
| DEVICE | SAPIEN 3 Ultra RESILIA THV | SAPIEN 3 Ultra RESILIA THV in the pulmonic position |
Timeline
- Start date
- 2016-07-05
- Primary completion
- 2026-12-01
- Completion
- 2031-06-01
- First posted
- 2016-04-20
- Last updated
- 2026-03-06
Locations
25 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT02744677. Inclusion in this directory is not an endorsement.