ALTERRA Post-Approval Study
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Phase
—
Status
Active, not recruiting
Study type
Observational
Enrollment
150actual
Sites
24
Countries
Israel, United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2022-05-12 | actual | When the study began enrolling |
| Primary completion | 2025-09-25 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Jul 2035 | estimated | The whole study's end, after follow-up |
| First posted | 2022-05-18 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-11-04 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Pulmonary Valve Insufficiency
- Complex Congenital Heart Defect
- Tetralogy of Fallot
- Pulmonary Regurgitation
- RVOT Anomaly
Intervention
- Device: Edwards Alterra Adaptive Prestent with SAPIEN 3 Transcatheter Pulmonary Valve System
Primary outcome
what the primary-completion date above is the date OFAcute Device Success
measured 24 hours post-procedure
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