VenTouch OUS Feasibility Study

NCT03616678 | Unknown DMC

• 1 other identifier: VenTouch CT007
• Study Type: interventional
• Target: 15
• Locations: 7 countries
• Sites: 12

Brief 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

Outcome Measures

Primary Outcomes (2)

• Evaluate procedural feasibility through successful completion of implant and therapy adjustment procedures

  Evaluate procedural feasibility through successful completion of implant and therapy adjustment procedures and intraoperative transesophageal echocardiographic (TEE) evidence of MR severity reduction (a minimum of one grade)

  Intra-operative

• Evaluate SAE Rates

  Evaluate Serious Adverse Event (SAE) rates at 1 month post-therapy adjustment

  1 Month

Secondary Outcomes (6)

• Evaluate SAE Rates

  36 Months

• Evaluate MR Severity

  36 Months

• Evaluate Reverse Ventricular Remodeling

  36 Months

• Evaluate Changes in Patient Symptoms by NYHA

  36 Months

• Evaluate Changes in Patient Functional Status by Six-Minute Walk

  36 Months

Study Arms (1)

VenTouch System Implant

EXPERIMENTAL

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 indicated for subjects with FMR with essentially normal leaflet anatomy and motion, with mitral valve regurgitation attributable to annular and/or ventricular dilation. It is not intended to treat structural defects/degeneration of the mitral valve. The VenTouch System is intended to provide ventricular support that will encourage beneficial remodeling of the heart and, with adjustable inflatable chambers, it is intended to reduce annular dilation, correct papillary muscle displacement, and restore mitral valve leaflet coaptation, allowing proper closure of the valve, and reducing or eliminating MR. The VenTouch System is indicated for patients who have "moderately severe" or "severe" mitral regurgitation (grade 3 or 4 MR).

Device: VenTouch System

Interventions

VenTouch System DEVICE

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.

VenTouch System Implant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults ≥18 years of age
• Symptomatic FMR of grade moderately severe to severe (3 to 4) due to either ischemic or non-ischemic dilated cardiomyopathy with structurally normal leaflets determined by echocardiography (preferably with echocardiographic evidence of EROA ≥ 0.20 cm2)
• NYHA Class II to IV
• Left Ventricular Ejection Fraction (LVEF) 20%-50% determined by echocardiography
• Treatment and compliance with optimal guideline-directed medical therapy for heart failure for at least 30 days
• Subjects with a Class I indication for CRT implant according to current guidelines should have CRT implant prior to entry into the study. Subjects who have existing CRT implants may be included in the study if the implant has been in place for at least 90 days; reprogramming of an implanted CRT that results in increased biventricular pacing (from \<92% to ≥92%) must be in place for at least 30 days.
• Left Ventricular End Diastolic Diameter (LVEDD) of 55 to 80 mm as determined by echocardiography
• Indexed Left Ventricular End Diastolic Diameter (LVEDDi) of 30 to 40 mm/m2 (where LVEDDi is calculated by LVEDD/Body Surface Area (BSA))
• Subject is willing and available to return for study follow-up
• Subject or legal representative understands and provides signed informed consent for participation in study
• Acceptance of subject for trial enrollment after review of all subject baseline data by Study Selection Committee

You may not qualify if:

• Life expectancy of less than 12 months due to conditions other than cardiac status
• Anticipated need for LVAD or transplant within 12 months
• Chronic Obstructive Pulmonary Disease (COPD) requiring continuous home oxygen therapy or chronic outpatient oral steroid use
• American College of Cardiology / American Heart Association (ACC/AHA) Stage D heart failure
• Six-minute walk distance \< 150 meters
• Identified need for any cardiovascular surgery
• STS score that suggests prohibitive surgical risk as determined by Subject Selection Committee
• Untreated clinically significant coronary artery disease
• Any procedure, condition or cardiac anatomy that may impact or compromise the pericardial space (e.g. prior mitral valve surgery, CABG, epicardial pacing leads, pericarditis, or other procedure involving pericardial access)
• Percutaneous coronary intervention, acute coronary syndrome (e.g. STEMI or non-STEMI myocardial infarction, unstable angina) or clinically significant cardiac events (e.g. hypotension, syncope, arrhythmias, embolism, heart failure exacerbation or any hospitalization) within 30 days of enrollment
• Thoracic or cardiac surgery contraindication (e.g., acute respiratory distress, endocarditis, myocarditis, pericarditis)
• Significant structural abnormality of the mitral valve (e.g. flail leaflets, ruptured or elongated chordae, prolapsed valve, perforated valve leaflets, significant calcification in the annulus, or calcification in the leaflets that restricts motion)
• Severe symptomatic carotid stenosis
• Severe or sustained pulmonary hypertension, defined by resting pulmonary artery systolic (PAS) pressure ≥70 mmHg determined by echocardiography or right heart catheterization
• Physical evidence of right-sided congestive heart failure with echocardiographic evidence of moderate or severe right ventricular dysfunction or moderate to severe TR

Sponsors & Collaborators

• Mardil Medical: lead

Study Sites (12)

Libin Cardiovascular Institute, University of Calgary

Calgary, Alberta, T2N 4N1, Canada

NOT YET RECRUITING

University of British Columbia, St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

NOT YET RECRUITING

London Health Sciences Centre, University Hospital

London, Ontario, N6A 5A5, Canada

NOT YET RECRUITING

Toronto General Hospital

Toronto, Ontario, 4NU-470, Canada

RECRUITING

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

RECRUITING

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

Québec, Quebec, G1V4G5, Canada

RECRUITING

Bordeaux Heart University Hospital

Bordeaux, Pessac, 33604, France

WITHDRAWN

CardioVasculäres Centrum

Frankfurt, 60389, Germany

WITHDRAWN

Semmelweis University Heart and Vascular Center

Budapest, Hungary

RECRUITING

Leiden University Medical Center

Leiden, 2300 RC, Netherlands

WITHDRAWN

Pacifica Salud Hospital Punta Pacifica

Panama City, 0801, Panama

RECRUITING

Centralny Szpital Kliniczny MSWiA w Warszawia

Warsaw, 02-507, Poland

WITHDRAWN

Related Links

• Study Sponsor Website

Central Study Contacts

Sarah Hase, BS

CONTACT

763-710-4518; shase@mardil.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2018
• First Posted: August 6, 2018
• Study Start: March 25, 2019
• Primary Completion: May 31, 2021
• Study Completion: December 31, 2023
• Last Updated: September 9, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1); PA (1); PL (1); DE (1); FR (1); HU (1); CA (6)