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Evaluation of the Minimally Invasive VenTouch™ System in the Treatment of Functional Mitral Valve Regurgitation (FMR)

NCT02671799 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2020-09-09

No results posted yet for this study

Summary

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 \[FMR\].

Conditions

  • Functional Mitral Regurgitation

Interventions

DEVICE

VenTouch System Implant

The VenTouch System is intended for use in the treatment of functional MR (FMR) in adults who are symptomatic despite optimal medical management. It is intended for subjects with FMR with essentially normal leaflet anatomy and motion, with mitral valve regurgitation attributable mainly to annular dilatation with or without papillary muscle displacement. It is not intended to treat structural defects/degeneration of the mitral valve. The VenTouch System is used to reshape the base of the heart to bring the mitral valve leaflets into better coaptation. By doing so, it brings the mitral valve leaflets closer, allowing proper closure of the valve, and reducing or eliminating MR. There is provision of support to the ventricular myocardium below the annulus as well as the annulus, so the VenTouch System may allow long-term ventricular remodeling with positive impact on the functionality of the mitral valve.

Sponsors & Collaborators

  • Mardil Medical

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2017-07-04
Completion
2020-12-31

Countries

  • Czechia
  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02671799 on ClinicalTrials.gov