VenTouch OUS Feasibility Study

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

Study Overview

• Status: Recruiting
• Conditions: Functional Mitral Regurgitation
• Intervention / Treatment: Device: VenTouch System

Detailed Description

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 enrolling up to 15 subjects who have been diagnosed with Grade 3-4 functional mitral valve regurgitation and deemed eligible per assessment by the inclusion/exclusion criteria. 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, 3, 6, 12, 24, and 36 months post-therapy adjustment.

• Study Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sarah Hase, BS; Phone Number: 763-710-4518; Email: shase@mardil.com

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4N1
      • Not yet recruiting
      • Libin Cardiovascular Institute, University of Calgary
      • Contact: William Kent, MD; Phone Number: 403-944-5480; Email: william.kent@albertahealthservices.ca
  • British Columbia
    • Vancouver, British Columbia, Canada, V6Z 1Y6
      • Not yet recruiting
      • University of British Columbia, St. Paul's Hospital
      • Contact: Catherin Mok; Phone Number: 604-806-8383; Email: CMok@providencehealth.bc.ca
      • Principal Investigator: Anson Cheung, MD
  • Ontario
    • London, Ontario, Canada, N6A 5A5
      • Not yet recruiting
      • London Health Sciences Centre, University Hospital
      • Contact: Stephanie Fox, BA, RRT; Phone Number: 35031 519-685-8500; Email: Stephanie.Fox@lhsc.on.ca
      • Principal Investigator: Dave Nagpal, MD
    • Toronto, Ontario, Canada, 4NU-470
      • Recruiting
      • Toronto General Hospital
      • Principal Investigator: Vivek Rao, MD, PhD
  • Quebec
    • Montreal, Quebec, Canada, H1T 1C8
      • Recruiting
      • Montreal Heart Institute
      • Principal Investigator: Anita Asgar, MD
      • Contact: Manon Vervais; Phone Number: 3783 514-376-3330; Email: manon.vervais@icm-mhi.org
      • Sub-Investigator: Denis Bouchard, MD
    • Québec City, Quebec, Canada, G1V4G5
      • Recruiting
      • Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ)
      • Contact: Hugo Tremblay; Phone Number: 3797 418-656-8711; Email: hugo.tremblay@criucpq.ulaval.ca
      • Principal Investigator: François Dagenais, MD
• France
  • Pessac
    • Bordeaux, Pessac, France, 33604
      • Withdrawn
      • Bordeaux Heart University Hospital
• Germany
  • Frankfurt, Germany, 60389
    • Withdrawn
    • CardioVasculäres Centrum
• Hungary
  • Budapest, Hungary
    • Recruiting
    • Semmelweis University Heart and Vascular Center
    • Principal Investigator: Bela Merkely, MD, PhD
    • Contact: Orsolya Kemenes; Phone Number: +36 20 8250511; Email: studycenter.sekk@gmail.com
• Netherlands
  • Leiden, Netherlands, 2300 RC
    • Withdrawn
    • Leiden University Medical Center
• Panama
  • Panama City, Panama, 0801
    • Recruiting
    • Pacifica Salud Hospital Punta Pacifica
    • Contact: Margelis Muñoz; Phone Number: (507) 6499-9304; Email: margelismunoz@gmail.com
    • Contact: Christian Marin y Kall; Phone Number: 305-799-1435; Email: marinykallch@hotmail.com
    • Principal Investigator: Manuel Ochoa, MD
• Poland
  • Warsaw, Poland, 02-507
    • Withdrawn
    • Centralny Szpital Kliniczny MSWiA w Warszawia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Adults ≥18 years of age
2. 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)
3. NYHA Class II to IV
4. Left Ventricular Ejection Fraction (LVEF) 20%-50% determined by echocardiography
5. Treatment and compliance with optimal guideline-directed medical therapy for heart failure for at least 30 days
6. 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.
7. Left Ventricular End Diastolic Diameter (LVEDD) of 55 to 80 mm as determined by echocardiography
8. Indexed Left Ventricular End Diastolic Diameter (LVEDDi) of 30 to 40 mm/m2 (where LVEDDi is calculated by LVEDD/Body Surface Area (BSA))
9. Subject is willing and available to return for study follow-up
10. Subject or legal representative understands and provides signed informed consent for participation in study
11. Acceptance of subject for trial enrollment after review of all subject baseline data by Study Selection Committee

Exclusion Criteria:

1. Life expectancy of less than 12 months due to conditions other than cardiac status
2. Anticipated need for LVAD or transplant within 12 months
3. Chronic Obstructive Pulmonary Disease (COPD) requiring continuous home oxygen therapy or chronic outpatient oral steroid use
4. American College of Cardiology / American Heart Association (ACC/AHA) Stage D heart failure
5. Six-minute walk distance < 150 meters
6. Identified need for any cardiovascular surgery
7. STS score that suggests prohibitive surgical risk as determined by Subject Selection Committee
8. Untreated clinically significant coronary artery disease
9. 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)
10. 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
11. Thoracic or cardiac surgery contraindication (e.g., acute respiratory distress, endocarditis, myocarditis, pericarditis)
12. 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)
13. Severe symptomatic carotid stenosis
14. Severe or sustained pulmonary hypertension, defined by resting pulmonary artery systolic (PAS) pressure ≥70 mmHg determined by echocardiography or right heart catheterization
15. Physical evidence of right-sided congestive heart failure with echocardiographic evidence of moderate or severe right ventricular dysfunction or moderate to severe TR
16. Hypotension (systolic pressure <90 mmHg)
17. Hemodynamic instability requiring inotropic support or mechanical heart assistance within 30 days
18. Hypertrophic cardiomyopathy, restrictive cardiomyopathy, or any other structural heart disease causing heart failure other than dilated cardiomyopathy
19. UNOS status 1 heart transplantation
20. Creatinine > 2.5 mg/dL (221 µmol/L) and/or renal failure requiring dialysis
21. Stroke (cerebrovascular accident) or transient ischemic event (TIA) within 30 days of enrollment
22. Active systemic infection or bleeding
23. Autoimmune disorders and/or the use of immune suppression therapy
24. Females who are pregnant (as documented by HCG beta pregnancy test in females of child-bearing age) or lactating
25. Currently enrolled in another investigational drug or device study

Intra-Operative Exclusion Criteria:

1. 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)
2. Signs/indications of ischemia
3. Intra-operative coronary angiography demonstrates that there is compression of the coronary arteries or reduction in coronary blood flow due to the VenTouch implant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate SAE Rates	Evaluate Serious Adverse Event (SAE) rates	36 Months
Evaluate MR Severity	Evaluate MR severity reduction and mitral valve dimension reduction via echocardiographic core lab assessment	36 Months
Evaluate Reverse Ventricular Remodeling	Evaluate reverse ventricular remodeling via echocardiographic core lab assessment	36 Months
Evaluate Changes in Patient Symptoms by NYHA	Evaluate changes in patient symptoms as assessed by the NYHA functional class	36 Months
Evaluate Changes in Patient Functional Status by Six-Minute Walk	Evaluate changes in patient functional status as assessed by Six-Minute Walk	36 Months
Evaluate Changes in Patient Functional Status by KCCQ	Evaluate changes in patient functional status as assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ)	36 Months

Collaborators and Investigators

• Sponsor: Mardil Medical

Publications and helpful links

Helpful Links

• Study Sponsor Website

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2019
• Primary Completion (Anticipated): May 31, 2021
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: July 24, 2018
• First Submitted That Met QC Criteria: July 31, 2018
• First Posted (Actual): August 6, 2018

Study Record Updates

• Last Update Posted (Actual): September 9, 2020
• Last Update Submitted That Met QC Criteria: September 8, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Mitral Valve Insufficiency
• Other Study ID Numbers: VenTouch CT007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No