Trials / Active Not Recruiting
Active Not RecruitingNCT03130777
ALTERRA: SAPIEN 3 THV With the Alterra Adaptive Prestent
Multicenter Study of Congenital Pulmonic Valve Dysfunction Studying the SAPIEN 3 THV With the Alterra Adaptive Prestent
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 86 (actual)
- Sponsor
- Edwards Lifesciences · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
To demonstrate the safety and effectiveness of the Edwards Alterra Adaptive Prestent in conjunction with the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) System in subjects with a dysfunctional right ventricular outflow tract/pulmonary valve (RVOT/PV) who are indicated for treatment of pulmonary regurgitation (PR). Following completion of enrollment, subjects will be eligible for enrollment in the continued access phase of the trial.
Conditions
- Pulmonary Disease
- Transcatheter Pulmonary Valve Replacement (TPVR)
- Tetralogy of Fallot
- Congenital Heart Disease
- Pulmonary Regurgitation
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Edwards Alterra Adaptive Prestent with SAPIEN 3 THV | The Edwards Alterra Adaptive Prestent is designed to reduce the diameter of large irregular RVOTs and provide a circular, semi-rigid landing zone to place an Edwards SAPIEN 3 THV. |
Timeline
- Start date
- 2017-08-22
- Primary completion
- 2022-07-14
- Completion
- 2032-06-01
- First posted
- 2017-04-26
- Last updated
- 2025-09-25
- Results posted
- 2023-08-08
Locations
14 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03130777. Inclusion in this directory is not an endorsement.