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

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-IVa (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

- 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 IVb (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 an 20F
system)

- 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