SAPIEN M3 EFS: Early Feasibility Study of the Edwards SAPIEN M3 System for the Treatment of Mitral Regurgitation
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Phase
Not applicable
Status
Active, not recruiting
Study type
Interventional
Design
Na · None · Device feasibility
Enrollment
72actual
Sites
9
Countries
Canada, United States
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 | 2017-09-14 | actual | When the study began enrolling |
| Primary completion | 2021-06-16 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2027-08-31 | estimated | The whole study's end, after follow-up |
| First posted | 2017-07-26 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-17 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Mitral Regurgitation
- Mitral Disease
Intervention
- Device: Edwards SAPIEN M3 System
Primary outcome
what the primary-completion date above is the date OFTechnical Success
measured At the end of the procedure
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