Real World Data Collection on the INSPIRIS RESILIA Aortic Valve
← catalyst calendarNCT07120048 · readout ≤ 134 d
Sponsored by Edwards Lifesciences (industry) · EW — their whole pipeline →.
Phase
—
Status
Recruiting
Study type
Observational
Enrollment
500estimated
Sites
14
Country
Germany
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 | 2025-07-30 | actual | When the study began enrolling |
| Primary completion | Dec 2026 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Dec 2026 | estimated | The whole study's end, after follow-up |
| First posted | 2025-08-13 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-06-22 | 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 Disease
Intervention
- Device: Edwards INSPIRIS RESILIA Aortic Valve
Primary outcomes
what the primary-completion date above is the date OFSubject's average mean gradient measurement over time
measured Prior to discharge (an average of 7 to 10 days after surgery) and at 3 months
Subject's average peak gradient measurement over time
measured Prior to discharge (an average of 7 to 10 days after surgery) and at 3 months
Amount of aortic transvalvular regurgitation in subjects over time
measured Prior to discharge (an average of 7 to 10 days after surgery) and at 3 months
Amount of aortic paravalvular regurgitation in subjects over time
measured Prior to discharge (an average of 7 to 10 days after surgery) and at 3 months
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