heart failure and reduced ejection fraction
This is a non-randomized, prospective, multi-center Early Feasibility Study to evaluate the AccuCinch® Ventricular Repair System in Patients with Heart Failure and Reduced Ejection Fraction (HFrEF).
- 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