VenTouch OUS Feasibility Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of The Minimally Invasive VenTouch™ System in The Treatment of Functional Mitral Valve Regurgitation (FMR): OUS Feasibility Study

Conditions
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Functional Mitral Regurgitation

Intervention / Treatment
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* Device: VenTouch System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 Hypotension (systolic pressure <90 mmHg) Hemodynamic instability requiring inotropic support or mechanical heart assistance within 30 days Hypertrophic cardiomyopathy, restrictive cardiomyopathy, or any other structural heart disease causing heart failure other than dilated cardiomyopathy UNOS status 1 heart transplantation Creatinine > 2.5 mg/dL (221 µmol/L) and/or renal failure requiring dialysis Stroke (cerebrovascular accident) or transient ischemic event (TIA) within 30 days of enrollment Active systemic infection or bleeding Autoimmune disorders and/or the use of immune suppression therapy Females who are pregnant (as documented by HCG beta pregnancy test in females of child-bearing age) or lactating Currently enrolled in another investigational drug or device study Intra-Operative Exclusion Criteria: 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) Signs/indications of ischemia Intra-operative coronary angiography demonstrates that there is compression of the coronary arteries or reduction in coronary blood flow due to the VenTouch implant

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VenTouch System Implant<br>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<br>* 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.<br>|

What is the study measuring?
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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 |