VenTouch OUS Feasibility Study

NAUnknownINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

March 25, 2019

Primary Completion Date

May 31, 2021

Study Completion Date

December 31, 2023

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."

Trial Locations (12)

33604

WITHDRAWN

Bordeaux Heart University Hospital, Bordeaux

60389

WITHDRAWN

CardioVasculäres Centrum, Frankfurt

T2N 4N1

NOT_YET_RECRUITING

Libin Cardiovascular Institute, University of Calgary, Calgary

V6Z 1Y6

NOT_YET_RECRUITING

University of British Columbia, St. Paul's Hospital, Vancouver

N6A 5A5

NOT_YET_RECRUITING

London Health Sciences Centre, University Hospital, London

4NU-470

RECRUITING

Toronto General Hospital, Toronto

H1T 1C8

RECRUITING

Montreal Heart Institute, Montreal

G1V4G5

RECRUITING

Institut Universitaire de Cardiologie et de Pneumologie De Québec (IUCPQ), Québec

Unknown

RECRUITING

Semmelweis University Heart and Vascular Center, Budapest

2300 RC

WITHDRAWN

Leiden University Medical Center, Leiden

0801

RECRUITING

Pacifica Salud Hospital Punta Pacifica, Panama City

02-507

WITHDRAWN

Centralny Szpital Kliniczny MSWiA w Warszawia, Warsaw

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Mardil Medical

INDUSTRY