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
Anthony Bell - anthony.bell@vandaliahealth.org
Research Contact
Anthony Bell - anthony.bell@vandaliahealth.org
Departments
Sex
All
Age
18+
Compensation
Not applicable
NCT Number
NCT04331769
IRB Number
23-954
Phase(s)
Not applicable