Early Feasibility Study of the AccuCinch® Ventricular Restoration System (5017) in Patients with Heart Failure and Reduced Ejection Fraction (HFrEF)
About
Protocol Description
Multi-center, non-randomized, prospective early feasibility study. The objective of this trial is to evaluate the safety and performance of the AccuCinch system in patients with heart failure with reduced ejection fraction (HFrEF). Enrollment has closed.
Find additional information here.
Eligibility Criteria
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
Exclusion Criteria
See inclusion criteria.
Primary Investigator
Jason Foerst, M.D.
Medical director of the Structural Heart and Valve Center at Carilion Clinic and an assistant professor of Medicine at the Virginia Tech Carilion School of Medicine.
Contact Information
Christina Bryant, R.N., R.C.I.S.
Clinical Research Nurse Coordinator
