- Conditions
- Pulmonary Valve Insufficiency, Complex Congenital Heart Defect, Tetralogy of Fallot, Pulmonary Regurgitation, RVOT Anomaly
- Interventions
- Edwards Alterra Adaptive Prestent with SAPIEN 3 Transcatheter Pulmonary Valve System
- Device
- Lead sponsor
- Edwards Lifesciences
- Industry
- Eligibility
- Not listed
- Enrollment
- 150 participants
- Healthy volunteers
- Healthy volunteers not accepted
- Timeline
- 2022 – 2035
- U.S. locations
- 23
- States / cities
- Birmingham, Alabama • Little Rock, Arkansas • Los Angeles, California + 18 more
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- Conditions
- Pulmonary Disease, Transcatheter Pulmonary Valve Replacement (TPVR), Tetralogy of Fallot, Congenital Heart Disease, Pulmonary Regurgitation
- Interventions
- Edwards Alterra Adaptive Prestent with SAPIEN 3 THV
- Device
- Lead sponsor
- Edwards Lifesciences
- Industry
- Eligibility
- Not listed
- Enrollment
- 86 participants
- Healthy volunteers
- Healthy volunteers not accepted
- Timeline
- 2017 – 2032
- U.S. locations
- 14
- States / cities
- Los Angeles, California • San Francisco, California • Aurora, Colorado + 10 more