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:

Treatment group: AccuCinch Ventricular Restoration System plus guideline-directed medical therapy (GDMT) (n~200)
Control group: Guideline-directed medical therapy (GDMT) (n~200)

Principal Investigator

Richard Han

Study Coordinator

Anthony Bell

Faculty Contact

Research Contact

Departments

Sex

All

Age

18+

Compensation

Not applicable

NCT Number

NCT04331769

IRB Number

23-954

Phase(s)

Not applicable