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VenTouch OUS Feasibility Study

NCT03616678 · 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 safety and efficacy of the VenTouch System for treatment of subjects with functional MR.

Conditions

  • Functional Mitral Regurgitation

Interventions

DEVICE

VenTouch System

The VenTouch™ 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 the wall of a knitted polyester support. The VenTouch device is implanted around the base of the heart and positioned at the level of the atrio-ventricular (AV) groove and the adjacent ventricular muscle. The VenTouch device is composed of biocompatible, medical-grade silicone and polyester.

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
2019-03-25
Primary Completion
2021-05-31
Completion
2023-12-31

Countries

  • Canada
  • France
  • Germany
  • Hungary
  • Netherlands
  • Panama
  • Poland

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 NCT03616678 on ClinicalTrials.gov