Safety and Performance of the AccuCinch® System

Study Overview
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Brief Summary
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This is a single-arm, multi-center, open-label controlled study that will assess the safety and performance of the Accucinch System to induce left ventricular reverse remodeling and reduce the severity of functional mitral regurgitation in symptomatic adult patients with mitral regurgitation and left ventricular remodeling due to dilated cardiomyopathy (ischemic or non-ischemic etiology), who are of high operative risk.

Official Title
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Safety and Performance of the AccuCinch® Ventricular Repair System

Conditions
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Heart Failure, Mitral Valve Insufficiency

Intervention / Treatment
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* Device: Accucinch Implant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Study patient is an adult of legal consent age Severity of FMR: ≥ Moderate Ejection Fraction: ≥20 to ≤60% Symptom Status: NYHA II-IVa Treatment and compliance with optimal guideline directed medical therapy for heart failure for at least 1 month Surgical risk: Subject is eligible for cardiac surgery Exclusion Criteria: Patients with significant organic mitral valve pathology (e.g. myxomatous degeneration, mitral valve prolapse or flail leaflets) Myocardial infarction or any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 30 days Prior surgical, transcatheter, or percutaneous mitral valve intervention Untreated clinically significant coronary artery disease requiring revascularization Hemodynamic instability: Hypotension or requirement for inotropic support or mechanical hemodynamic support Any planned cardiac surgery or interventions within the next 6 months NYHA class IVb (i.e., non-ambulatory) or ACC/AHA Stage D heart failure Fixed pulmonary artery systolic pressure >70 mmHg Severe tricuspid regurgitation Modified Rankin Scale ≥ 4 disability 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 Mitral valve area less than 4.0 cm2 Anatomical pathology/constraints preventing appropriate access/implant of the GDS Accucinch System Renal insufficiency Mitral annular calcification 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 stroke within the prior 3 months Subjects in whom anticoagulation is contraindicated Anemia Thrombocytopenia or thrombocytosis Bleeding disorders or hypercoaguable state Active peptic ulcer or active gastrointestinal bleeding 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 or implantable cardioverter defibrillator within the prior month Absence of CRT with class I indication criteria for biventricular pacing - Subjects on high dose steroids or immunosuppressant therapy Female subjects who are pregnant, of child bearing potential 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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Accucinch Implant<br>Accucinch Implant procedure is completed | Device: Accucinch Implant<br>* Percutaneous implantation of the Accucinch Implant in the mitral subannular space<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The additive reduction in the mitral annular axial dimensions (anteroposterior plus commissure-to-commissure axes) measured via echocardiography, paired by subject | The differences between baseline and 6 months in the sum of the two annulus measures will be calculated for each subject and the mean change tested via the paired t-test. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device Success: Percentage of patients in whom all pre-specified device performance endpoints are met but no pre-specified device complications are met. | Pre-specified endpoints are the following:stroke-free survival AND intended positioning of the original implant AND No additional surgical or interventional procedures AND intended performance of the device (no migration, embolization, fracture, thrombosis, etc AND reduction of MR by at least one grade and reduction of combined mitral annular diameters by at least 20%) AND no device-related complications (erosion, migration, etc.) at 30-days and all subsequent follow-up time points. | 30 Days, 6 months, 12 months, and 2 years | 
| Procedural Safety: Incidence rate of the occurrence of the individual pre-specified safety events that occur within 30 days of the index procedure | Pre-specified safety events include the following: Death Stroke Life-threatening or Extensive bleeding (MVARC scale) Major vascular complications Major cardiac access (e.g., structural) complications Stage 2 or 3 acute kidney injury (AKI) New myocardial infarction or coronary insufficiency requiring PCI or CABG Severe hypotension, heart failure, or respiratory failure Any implant-related dysfunction or other complication requiring surgery or unplanned intervention or prolonged intubation > 24 hours | 30 days after the index procedure | 
| Long Term Safety: Incidence rate of the occurrence of the individual pre-specified safety events at 6 months, 1 year, and 2 years. | Pre-specified endpoints include the following: Death, cardiac, non-cardiac Stroke Mitral valve reintervention or surgery MI Any device related complication/ dysfunction New atrial fibrillation (AF) New conduction disturbance requiring permanent pacemaker (PM) | 6 months, 1 year, 2 years post index procedure |