MiCLASP Post Market Clinical Follow-Up (PMCF) Study
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Phase
—
Status
Active, not recruiting
Study type
Observational
Enrollment
1,000estimated
Sites
37
Countries
Austria, Germany, Greece +6
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 | 2019-08-23 | actual | When the study began enrolling |
| Primary completion | 2025-09-04 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2031-03-31 | estimated | The whole study's end, after follow-up |
| First posted | 2020-06-12 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-19 | 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 Insufficiency
Intervention
- Device: Edwards PASCAL Transcatheter Valve Repair System and Edwards PASCAL Precision Transcatheter Valve Repair System
Primary outcomes
what the primary-completion date above is the date OFNumber of patients with major adverse events (MAE rates)
measured 30 days
Change in mitral regurgitation severity (scale of 0-4+) by echocardiography
measured Discharge: defined as discharge or 7 days post-procedure, whichever comes first
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