INSPIRIS China PMCF Study
← catalyst calendarNCT05404880 · readout ≤ 865 d
Sponsored by Edwards Lifesciences (industry) · EW — their whole pipeline →. With Edwards (Shanghai) Lifesciences Medical Supplies Co., Ltd., Rundo International Pharmaceutical Research & Development Co.,Ltd., Chinese Academy of Medical Sciences, Fuwai Hospital.
Phase
—
Status
Active, not recruiting
Study type
Observational
Enrollment
255actual
Sites
13
Country
China
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 | 2022-07-13 | actual | When the study began enrolling |
| Primary completion | Dec 2028 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Dec 2029 | estimated | The whole study's end, after follow-up |
| First posted | 2022-06-03 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-03-25 | 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 Replacement
Intervention
- Device: EDWARDS INSPIRIS RESILIA Aortic Valve
Primary outcomes
what the primary-completion date above is the date OFSubject's Occurrence Rate of Study Valve Related Death
measured 5 Years
Subject's Occurrence Rate of Structural Valve Deterioration
measured 5 Years
Subject's Occurrence Rate of Re-operation on the Study Valve
measured 5 Years
Subject's Occurrence Rate of Major Bleeding
measured 5 Years
Subject's Occurrence Rate of Thromboembolic Events
measured 5 Years
Subject's Occurrence Rate of Stroke
measured 5 Years
Subject's Occurrence Rate of Transient Ischemic Attack
measured 5 Years
Subject's Occurrence Rate of Non-Cerebral Thromboembolism
measured 5 Years
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