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Evaluation of the Minimally Invasive VenTouch™ System in the Treatment of Functional Mitral Valve Regurgitation (FMR): First-In-Man Continuation Study
This is a prospective, multi-center, single-arm study to evaluate the VenTouch System for treatment of moderate to moderate-severe functional mitral valve regurgitation \[FMR\].
Details
| Lead sponsor | Mardil Medical |
|---|---|
| Phase | NA |
| Status | UNKNOWN |
| Enrolment | 15 |
| Start date | 2016-01 |
| Completion | 2020-12 |
Conditions
- Functional Mitral Regurgitation
Interventions
- VenTouch System Implant
Primary outcomes
- Evaluate mean reduction in MR, and freedom from grade 3 and 4 MR at 6 months post-therapy adjustment, as measured by an echocardiographic core lab — 6 months
- Evaluate Serious Adverse Event (SAE) rates at 6 months post-therapy adjustment — 6 months
Countries
Czechia, France