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).
Keywords
cardiac, heart, cardiovascular, cardiology, vascular, accucinch, ventricular, restoration, symptomatic, failure, hfref, reduced, ejection, fraction, ancora
Categories
Heart and Vascular
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