Randomized Clinical Evaluation of the AccuCinch® Ventricular Restoration System in Patients Who Present With Symptomatic Heart Failure With Reduced Ejection Fraction (HFrEF): The CORCINCH-HF Study
Prospective, randomized, open-label, international, multi-center clinical study to evaluate the safety and efficacy of the AccuCinch Ventricular Restoration System in patients with heart failure and reduced ejection fraction (HFrEF).
The CORCINCH-HF Study is a prospective, randomized, open-label, multicenter, international, clinical safety and efficacy investigation of the AccuCinch Ventricular Restoration System.
Subjects will be randomized in a 1:1 ratio:
1. Treatment group: AccuCinch Ventricular Restoration System plus guideline-directed medical therapy (GDMT) (n~200)
2. Control group: Guideline-directed medical therapy (GDMT) (n~200)
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Age 18-years or older
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Ejection Fraction: >20% and <40% measured by transthoracic echocardiography (TTE) and assessed by an echocardiography (echo) core lab
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LV end-diastolic diameter >55 mm measured by TTE and assessed by an echo core lab
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Symptom Status:
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NYHA III,
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NYHA ambulatory IV, or
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NYHA II with a heart failure hospitalization within the prior 12 months (of signing the consent)
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Able to complete six-minute walk test with distance between 100 m and 450 m
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Please contact study team for additional inclusion criteria
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Myocardial infarction or any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 90 days prior to consent
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Untreated clinically significant coronary artery disease (CAD) requiring revascularization
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Fluoroscopic or echocardiographic evidence of severe aortic arch calcification, mobile aortic atheroma, intracardiac mass, thrombus or vegetation
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Suboptimal ventricular anatomy or wall thickness as determined from screening echocardiography and/or CT scan
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Heart failure on the basis other than ischemic or non-ischemic dilated cardiomyopathy (e.g., hypertrophic cardiomyopathy, amyloid cardiomyopathy, restrictive cardiomyopathy, uncorrected congenital heart disease, constrictive pericarditis)
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Hemodynamic instability within 30 days prior to the implant defined as subject requiring inotropic support or mechanical hemodynamic support
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Please contact study team for additional exclusion criteria
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