SAPIEN 3 Ultra System PMCF
← catalyst calendarSponsored by Edwards Lifesciences (industry) · EW — their whole pipeline →.
Phase
—
Status
Active, not recruiting
Study type
Observational
Enrollment
200actual
Sites
11
Countries
Austria, Canada, Denmark +5
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 | 2020-06-30 | actual | When the study began enrolling |
| Primary completion | 2021-09-24 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Nov 2026 | estimated | The whole study's end, after follow-up |
| First posted | 2020-09-21 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-04-15 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Aortic Valve Stenosis
Intervention
- Device: SAPIEN 3 Ultra System
Primary outcome
what the primary-completion date above is the date OFDevice success per VARC-3, defined as meeting all of the following:
measured 30 days
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