NCT04331769

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Ancora Heart, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed 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)

Conditions

• Heart Failure With Reduced Ejection Fraction (HFrEF)
• Dilated Cardiomyopathy

Interventions

Type	Name	Description
DEVICE	AccuCinch Ventricular Restoration System	AccuCinch Ventricular Restoration System
DRUG	Guideline-Directed Medical Therapy	Guideline-Directed Medical Therapy

Timeline

• Start date: 2020-12-21
• Primary completion: 2026-12-31
• Completion: 2030-12-21
• First posted: 2020-04-02
• Last updated: 2025-12-11

Locations

132 sites across 10 countries: United States, Belarus, Belgium, Czechia, France, Germany, Greece, Italy, Netherlands, Serbia

Regulatory

• FDA-regulated device study