ALTERRA: SAPIEN 3 THV With the Alterra Adaptive Prestent
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Phase
Not applicable
Status
Active, not recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
86actual
Sites
14
Country
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 | 2017-08-22 | actual | When the study began enrolling |
| Primary completion | 2022-07-14 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Jun 2032 | estimated | The whole study's end, after follow-up |
| First posted | 2017-04-26 | actual | When this record first appeared on the registry |
| Results posted | 2023-08-08 | actual | When the sponsor posted results to the registry |
| Record updated | 2025-09-25 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Pulmonary Disease
- Transcatheter Pulmonary Valve Replacement (TPVR)
- Tetralogy of Fallot
- Congenital Heart Disease
- Pulmonary Regurgitation
Intervention
- Device: Edwards Alterra Adaptive Prestent with SAPIEN 3 THV
Primary outcomes
what the primary-completion date above is the date OFMain Cohort: THV Dysfunction
measured 6 months
PDS Registry: Acute PDS Success
measured 24 hours
Posted documents
hosted by the registry — we link, never re-serveStudy Protocol and Statistical Analysis Planposted 2021-12-16 · 727 KB · Prot_SAP_000.pdf
Publications
- PMID 41657206 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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