- Conditions
- Complex Congenital Heart Defect, Dysfunctional RVOT Conduit, Pulmonary Valve Insufficiency, Pulmonary Valve Degeneration
- Interventions
- SAPIEN 3/SAPIEN 3 Ultra RESILIA THV, SAPIEN 3 THV, SAPIEN 3 Ultra RESILIA THV
- Device
- Lead sponsor
- Edwards Lifesciences
- Industry
- Eligibility
- Not listed
- Enrollment
- 108 participants
- Healthy volunteers
- Healthy volunteers not accepted
- Timeline
- 2016 – 2031
- U.S. locations
- 25
- States / cities
- Little Rock, Arkansas • Los Angeles, California • San Francisco, 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