ALLIANCE: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve
← catalyst calendarNCT05172960 · readout ≤ 346 d
Sponsored by Edwards Lifesciences (industry) · EW — their whole pipeline →.
Phase
Not applicable
Status
Recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
1,234estimated
Sites
65
Countries
Australia, Canada, New Zealand +1
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 | 2022-06-20 | actual | When the study began enrolling |
| Primary completion | Jul 2027 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Jan 2037 | estimated | The whole study's end, after follow-up |
| First posted | 2021-12-29 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-11 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Aortic Stenosis, Severe
Interventions
- Device: SAPIEN X4 THV
- Device: SAPIEN X4S
Primary outcome
what the primary-completion date above is the date OFNon-hierarchical composite of death and stroke
measured 1 year
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