Early Feasibility Evaluation of the AccuCinch® Ventricular Restoration System in Patients With Heart Failure and Reduced Ejection Fraction

Study Overview
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Brief Summary
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This is a non-randomized, prospective, multi-center Early Feasibility Study to evaluate the AccuCinch® Ventricular Restoration System in Patients with Heart Failure and Reduced Ejection Fraction (HFrEF).

Detailed Description
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Device name changed from AccuCinch® Ventricular Repair System to AccuCinch® Ventricular Restoration System, FDA Approval Date 08Aug2020.

Official Title
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An Early Feasibility Evaluation of the AccuCinch® Ventricular Restoration System in Patients With Heart Failure and Reduced Ejection Fraction (HFrEF) - The CorCinch-HFrEF Study

Conditions
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Cardiomyopathy, Dilated, Heart Failure

Intervention / Treatment
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* Device: AccuCinch® Ventricular Restoration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Study patient is at least 18-years old Ejection Fraction: ≥20 and ≤40% LV end-diastolic diameter ≥55 mm Symptom Status: NYHA III-IV (i.e., ambulatory) Treatment and compliance with optimal guideline directed medical and device-based therapies for heart failure (unless contraindicated or intolerant) for at least 3 months and stable doses for 1 month with stable defined as no more than 100% increase or 50% decrease of total daily doses. Patients with left bundle branch block pattern and QRS duration >150ms are required to have a CRT device for at least 3 months Patients required to have an ICD are required to have ICD implant at least 1 month prior to enrollment Able and willing to complete all qualifying diagnostic and functional tests and agrees to comply with study follow-up schedule Exclusion Criteria: Myocardial infarction or any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 3 months Mitral regurgitation grade 3 (moderate-severe) or more Prior surgical, transcatheter, or percutaneous mitral valve intervention Untreated clinically significant coronary artery disease (CAD) requiring revascularization Hemodynamic instability: Hypotension (systolic pressure <90 mmHg) or requirement for inotropic support or mechanical hemodynamic support Any planned cardiac surgery or interventions within the next 6 months (including right heart procedures) NYHA class IV (i.e., non-ambulatory) Significant RV dysfunction (TAPSE < 14) Severe tricuspid regurgitation Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or any other structural heart disease causing heart failure other than dilated cardiomyopathy of either ischemic or non-ischemic etiology Anatomical pathology or constraints preventing appropriate access/implant of the AccuCinch® Ventricular Repair System (e.g., femoral arteries will not support a 20F system) Renal insufficiency (i.e., eGFR of <30ml/min/1.73m2; Stage 4 or 5 CKD) Moderate or severe aortic valve stenosis or regurgitation or aortic valve prosthesis Fluoroscopic or echocardiographic evidence of severe aortic arch calcification, mobile aortic atheroma, intracardiac mass, thrombus or vegetation Active bacterial endocarditis History of any stroke within the prior 3 months or Modified Rankin Scale ≥ 4 disability from any prior stroke Subjects in whom anticoagulation or antiplatelet therapy is contraindicated Known allergy to nitinol, polyester, or polyethylene Any prior true anaphylactic reaction to contrast agents; defined as known anaphylactoid or other non-anaphylactic allergic reactions to contrast agents that cannot be adequately pre-medicated prior to the index procedure. Life expectancy < 1 year due to non-cardiac conditions Currently participating in another interventional investigational study Implant or revision of any rhythm management device (CRT or CRT-D) prior 3 months or implantable cardioverter defibrillator within the prior 1 month Subjects on high dose steroids or immunosuppressant therapy Female subjects who are pregnant, of child bearing potential without a documented birth control method, or lactating

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: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AccuCinch® Ventricular Restoration System<br> | Device: AccuCinch® Ventricular Restoration<br>* AccuCinch® Ventricular Restoration System in Patients with Heart Failure and Reduced Ejection Fraction (HFrEF)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety measured by device-related or procedure-related major adverse events (MAEs) | Device-related or procedure-related major adverse events (MAEs) | 30-day |