Clinical Trial

VenTouch OUS Feasibility Study

Study Description

VenTouch OUS Feasibility Study

This is a prospective, multi-center, single-arm study to evaluate safety and efficacy of the VenTouch System for treatment of subjects with functional MR.

Location

Locations Selected Location

Methods

No pharmaceutical medication involved No pharmaceutical medication involved
Recruiting patients only Recruiting patients only

Device - VenTouch System

The VenTouchâ„¢ System consists of a delivery tool with a pre-loaded implant (VenTouch device) and accessories, which include a sizing tool, PEMS, chamber positioning tool, and accessories kit with luer fitting, tubing clamp, and titanium plug. The VenTouch device is offered in 6 sizes, with 4 different sized inflatable chambers available. Please refer to the VenTouch Instructions for Use for and system details. The VenTouch device consists of three (3) inflatable silicone chambers attached to t ...read more on ClinicalTrials.org

Additional Information

Official Study Title

Evaluation of The Minimally Invasive VenTouchâ„¢ System in The Treatment of Functional Mitral Valve Regurgitation (FMR): OUS Feasibility Study

Clinical Trial ID

NCT03616678

ParticipAid ID

epYgpa