VenTouch OUS Feasibility Study

Not Applicable

• Conditions: Functional Mitral Regurgitation
• Interventions: Device: VenTouch System

• Registration Number: NCT03616678
• Lead Sponsor: Mardil Medical

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.

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 Timeline

• Study First Submitted: 2018-07-24
• Study First Submitted QC: 2018-07-31
• Study First Posted: 2018-08-06
• Study Start: 2019-03-25
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-08
• Last Update Posted: 2020-09-09
• Primary Completion: 2021-05-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
VenTouch System Implant	VenTouch System	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).

Primary Outcome Measures

Name	Time	Method
Evaluate SAE Rates	1 Month	Evaluate Serious Adverse Event (SAE) rates at 1 month post-therapy adjustment
Evaluate procedural feasibility through successful completion of implant and therapy adjustment procedures	Intra-operative	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)

Secondary Outcome Measures

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

Trial Locations

Locations (12)

Montreal Heart Institute; 🇨🇦 Montreal, Quebec, Canada

Semmelweis University Heart and Vascular Center; 🇭🇺 Budapest, Hungary

Institut Universitaire de Cardiologie et de Pneumologie De Québec (IUCPQ); 🇨🇦 Québec City, Quebec, Canada

Centralny Szpital Kliniczny MSWiA w Warszawia; 🇵🇱 Warsaw, Poland

Pacifica Salud Hospital Punta Pacifica; 🇵🇦 Panama City, Panama

Bordeaux Heart University Hospital; 🇫🇷 Bordeaux, Pessac, France

Libin Cardiovascular Institute, University of Calgary; 🇨🇦 Calgary, Alberta, Canada

University of British Columbia, St. Paul's Hospital; 🇨🇦 Vancouver, British Columbia, Canada

London Health Sciences Centre, University Hospital; 🇨🇦 London, Ontario, Canada

CardioVasculäres Centrum; 🇩🇪 Frankfurt, Germany

Leiden University Medical Center; 🇳🇱 Leiden, Netherlands

Toronto General Hospital; 🇨🇦 Toronto, Ontario, Canada