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
Ancora Heart, Inc.
Summary
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).
Description
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)
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Age 18-years or older 2. Ejection Fraction: ≥20% and ≤40% measured by transthoracic echocardiography (TTE) and assessed by an echocardiography (echo) core lab 3. LV end-diastolic diameter ≥55 mm measured by TTE and assessed by an echo core lab 4. Symptom Status: 1. NYHA III, 2. NYHA ambulatory IV, or 3. NYHA II with a heart failure hospitalization within the prior 12 months (of signing the consent) 5. Able to complete six-minute walk test with distance between 100 m and 450 m. 6. Diagnosis and treatment for heart failure should be established at least 90 days…
Interventions
- DeviceAccuCinch Ventricular Restoration System
AccuCinch Ventricular Restoration System
- DrugGuideline-Directed Medical Therapy
Guideline-Directed Medical Therapy
Locations (132)
- Grandview Medical Group Research, LLCBirmingham, Alabama
- University of Alabama at BirminghamBirmingham, Alabama
- Dignity Health St. Joseph's Hospital and Medical CenterPhoenix, Arizona
- Phoenix Cardiovascular Research GroupPhoenix, Arizona
- Tucson Medical CenterTucson, Arizona
- Baptist Health Heart Failure & Transplant InstituteLittle Rock, Arkansas