Trials / Active Not Recruiting
Active Not RecruitingNCT05378386
ALTERRA Post-Approval Study
Multicenter Post-Approval Study of Congenital Pulmonic Valve Dysfunction Studying the Edwards SAPIEN 3 Transcatheter Pulmonary Valve System With Alterra Adaptive Prestent
- 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 in subjects undergoing implantation of the Edwards SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra Adaptive Prestent in the post-approval setting
Detailed description
This is a single arm, prospective, multicenter post-approval study.
Conditions
- Pulmonary Valve Insufficiency
- Complex Congenital Heart Defect
- Tetralogy of Fallot
- Pulmonary Regurgitation
- RVOT Anomaly
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Edwards Alterra Adaptive Prestent with SAPIEN 3 Transcatheter Pulmonary Valve System | The Edwards Alterra Adaptive Prestent is designed to reduce the diameter of large irregular right ventricular outflow tracts (RVOTs) and provide a circular, semi-rigid landing zone to place an Edwards SAPIEN 3 transcatheter heart valve (THV). |
Timeline
- Start date
- 2022-05-12
- Primary completion
- 2025-09-25
- Completion
- 2035-07-01
- First posted
- 2022-05-18
- Last updated
- 2025-11-04
Locations
24 sites across 2 countries: United States, Israel
Source: ClinicalTrials.gov record NCT05378386. Inclusion in this directory is not an endorsement.