- 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
- Hypoplastic Left Heart Syndrome, Total Anomalous Pulmonary Venous Return, Truncus Arteriosus, Pulmonary Atresia With Ventricular Septal Defect, Transposition of the Great Arteries, Double Outlet Right Ventricle, Subpulmonary VSD, Tetralogy of Fallot, Double Outlet Right Ventricle With Subaortic Ventricular Septal Defect and Pulmonary Stenosis, Cardiopulmonary Bypass
- Interventions
- Normoxia (with controlled re-oxygenation), Standard of care ventilation
- Other
- Lead sponsor
- University of Michigan
- Other
- Eligibility
- Up to 29 Days
- Enrollment
- 29 participants
- Healthy volunteers
- Healthy volunteers not accepted
- Timeline
- 2021 – 2023
- U.S. locations
- 1
- States / cities
- Ann Arbor, Michigan