MITRIS China Post Market Clinical Follow-up (PMCF) Study
← catalyst calendarNCT07059793 · readout ≤ 865 d
Sponsored by Edwards Lifesciences (industry) · EW — their whole pipeline →. With Edwards (Shanghai) Medical Products Co. Ltd., Kun Tuo Medical Research and Development (Beijing) Co. Ltd., Chinese Academy of Medical Sciences, Fuwai Hospital.
Phase
—
Status
Recruiting
Study type
Observational
Enrollment
250estimated
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 | 2025-07-08 | 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 2038 | estimated | The whole study's end, after follow-up |
| First posted | 2025-07-11 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-12-30 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Mitral Valve Replacement
Intervention
- Device: MITRIS RESILIA Mitral Valve
Primary outcomes
what the primary-completion date above is the date OFPrimary Safety outcome - Kaplan Meier (KM) rate of valve related death or reintervention
measured 1 year
Primary Performance outcome - Hemodynamics by echocardiography - Subject's Average Mean Gradient Measurements
measured 1 year
Primary Performance outcome - Hemodynamics by echocardiography - Subject's Average Peak Gradients Measurements
measured 1 year
Primary Performance outcome - Hemodynamics by echocardiography - Subject's Amount of Transvalvular regurgitation
measured 1 year
Primary Performance outcome - Hemodynamics by echocardiography - Subject's Amount of Paravalvular leak
measured 1 year
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