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
- Study HIC#:2000028335
- Last Updated:05/07/2024
The CORCINCH-HF Study is evaluating the safety and efficacy of the AccuCinch® Ventricular Restoration System, a new and innovative device-based approach to treating heart failure that is designed to improve the structure and function of the heart and may help reduce symptoms, improve quality of life and potentially increase life expectancy.
During the minimally invasive AccuCinch procedure, a flexible implant is attached to the interior of the mid left ventricular wall and then cinched. The implant is intended to reduce the size of the left ventricle, reduce ventricular wall stress, and support and strengthen the heart wall.
- Age18 years and older
- GenderBoth
Contact Us
For more information about this study, including how to volunteer, contact:
Arben Ademi, MD, CCRP
- Phone Number: 1-203-785-7633
Help Us Discover!
You can help our team find trials you might be eligible for by creating a volunteer profile in MyChart. To get started, create a volunteer profile, or contact helpusdiscover@yale.edu, or call +18779788343 for more information.
Trial Purpose and Description
The CORCINCH-HF Study is evaluating the safety and efficacy of the AccuCinch® Ventricular Restoration System, a new and innovative device-based approach to treating heart failure that is designed to improve the structure and function of the heart and may help reduce symptoms, improve quality of life and potentially increase life expectancy.
During the minimally invasive AccuCinch procedure, a flexible implant is attached to the interior of the mid left ventricular wall and then cinched. The implant is intended to reduce the size of the left ventricle, reduce ventricular wall stress, and support and strengthen the heart wall.
Eligibility Criteria
The CORCINCH-HF Study includes heart centers from around the world, including Yale New Haven Hospital. Enrolled patients will be randomized to receive treatment with the AccuCinch System or guideline-directed medical therapy.
- To be eligible, patients must meet the following main criteria:
- Ejection Fraction ≥20% and ≤40%
- NYHA II (with a HF hospitalization in the past 12 months), III or IV (ambulatory)
- LV end-diastolic diameter of ≥55 mm
- Able to complete a six-minute walk test with a distance between 100m and 450m
Principal Investigator
- Score: 1
