Randomized Clinical Evaluation of the AccuCinch® Ventricular Restoration System
This study allows Carilion to offer alternative options for patients with complex heart failure conditions. It is a randomized clinical Evaluation of the AccuCinch® Ventricular Restoration System (5019) in patients who present with symptomatic HFrEF.
Protocol Description
CORCINCH-HF 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.
a) Treatment group: AccuCinch Ventricular Restoration System (n~200) plus guideline-directed medical therapy (GDMT)
b) Control group: Guideline-directed medical therapy (GDMT) (n~200)
Eligibility Criteria
Inclusion Criteria
- Ejection fraction: ≥20 and ≤40%
- LV end-diastolic diameter ≥55 mm
- Symptom status: a. NYHA III, b. NYHA ambulatory IV, or c. NYHA II with a heart failure hospitalization within the prior 12 months (of signing the consent)
- Able to complete 6-minute walk test with distance between 100 m and 450 m
- Treatment with guideline-directed medical and device-based therapies for heart failure
- A CRT device, which is required for at least 90 days prior to baseline screening in subjects with left bundle branch block pattern and QRS duration >150 ms
- An ICD, which is required for all patients in whom it is indicated (based on best local clinical practice) for at least 30 days prior to baseline screening
Exclusion Criteria
- Suboptimal ventricular anatomy or wall thickness as determined from baseline echocardiography and CT scan, with final determination made by the Eligibility Committee
- Fluoroscopic or echocardiographic evidence of severe aortic arch calcification, mobile aortic atheroma, intracardiac mass, thrombus or vegetation
- Mitral regurgitation grade 3+ (moderate-severe) or 4+ (severe)
- Prior mitral or aortic valve replacement
- Severe (≥3+) tricuspid regurgitation
- Moderate or severe aortic valve stenosis (AVA less than 1.5 cm2 or outflow velocity >300 cm/sec 17, Aortic regurgitation ≥2+)
Primary Investigator
Jason Foerst, MD, is is Medical Director of the Structural Heart and Valve Center at Carilion Clinic, Assistant Professor of Medicine at Virginia Tech–Carilion School of Medicine, and Director of Carilion Clinic's Structural Heart Disease fellowship program. Dr Foerst is a structural interventional cardiologist and researcher who completed his internship, residency, and fellowship training at Dartmouth–Hitchcock/Mary Hitchcock Memorial Hospital.
