NCT02671799

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

Evaluation of the Minimally Invasive VenTouch™ System in the Treatment of Functional Mitral Valve Regurgitation (FMR): First-In-Man Continuation Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Mardil Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 \[FMR\].

Detailed description

This trial is a prospective, multi-center, single-arm First-In-Man Continuation study to evaluate safety and efficacy of the VenTouch System for treatment of subjects with functional MR enrolling up to 15 subjects who have been diagnosed with Grade 3-4 functional mitral valve regurgitation. The duration of the study follow-up is 36 months from the time of therapy adjustment. Data from this trial may be utilized in support of a CE study in Europe and/or a pilot IDE study in the U.S. Follow-up testing will be performed at 1 month, 3 months, 6 months, and 12, 24, and 36 months post-therapy adjustment.

Conditions

• Functional Mitral Regurgitation

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-01-01
• Primary completion: 2017-07-04
• Completion: 2020-12-01
• First posted: 2016-02-02
• Last updated: 2020-09-09

Locations

2 sites across 2 countries: Czechia, France