Heart failure centers are accepting patients for a clinical trial of a minimally invasive therapy for heart patients with reduced ejection fraction.

Norton Heart & Vascular Institute is the only site in Kentucky or Indiana participating in the CORCINCH-HF study to evaluate the safety and efficacy of the AccuCinch Ventricular Restoration System. The implanted device is designed to improve heart structure and function by both reducing the size of the left ventricle and supporting and strengthening the wall of the heart. An enlarged left ventricle contributes to heart failure symptoms.

During the catheter-based procedure, a flexible implant is attached to the inner wall of the left ventricle and then cinched to pull in the heart wall, making the left ventricle smaller. The goal of the system is to provide an intermediate treatment after medication stops providing adequate symptom relief. Currently, the next step is mechanical circulatory support, such as a left ventricular assist device, or heart transplant.

By reducing the size of the left ventricle and reducing ventricular wall stress, the ventricular restoration system is intended to initiate a structural heart remodeling that improves myocardial contractions and heart function.

The Food and Drug Administration (FDA) has designated the AccuCinch System as a breakthrough device, expediting its review toward possible FDA approval.

“If the trial is successful, the device has the potential to reduce heart failure symptoms that can lead to disease progression, improve quality of life, and increase life expectancy — without open heart surgery,” said Kelly C. McCants, M.D., executive medical director of the Norton Heart & Vascular Institute Advanced Heart Failure & Recovery Program. Dr. McCants is also executive director of the Institute for Health Equity, a Part of Norton Healthcare.

CORCINCH-HF study guidelines

The CORCINCH-HF study, listed at ClinicalTrials.gov as NCT04331769, is an open-label, multicenter, randomized clinical trial for symptomatic heart failure patients. Patients participating in this study will receive treatment with the AccuCinch System and guideline-directed medical therapy (GDMT) or medical therapy alone.

Norton Heart & Vascular Institute has enrolled its first patient in the study, sponsored by Ancora Heart Inc., which hopes to enroll 400 patients worldwide.

To be included in the study, a patient must be age 18 or older with an ejection fraction between 20% and 40%, measured by transthoracic echocardiography (TTE) and assessed by an echocardiography (echo) core lab, and also have left ventricle end-diastolic diameter equal to or greater than 55 millimeters measured by TTE and assessed by an echo core lab.

Heart failure patients must be in New York Heart Association (NYHA) ambulatory IV II with a heart failure hospitalization within 12 months prior to signing the consent. They also must be able to complete a six-minute walk test with distance between 100 meters and 450 meters.

Diagnosis and treatment for heart failure should be established at least 90 days before the date of consent. Study participants should be on stable, optimally titrated medical therapy for at least 30 days, as recommended according to current guidelines as standard-of-care for heart failure therapy, with any intolerance documented.

Study subjects must be able and willing to complete all qualifying diagnostic and functional tests, willing to accept blood product transfusion if required, and agree to comply with the study follow-up schedule.

Norton Heart & Vascular Institute’s participation in the CORCINCH-HF study is another example of the center’s commitment to research that provides innovative care.

Norton Heart & Vascular Institute was first in the region to offer computed tomography fractional flow reserve (CT-FFR) imaging analysis and designed it as best practice more than three years ahead of the American College of Cardiology/ American Heart Association guidelines change.

Norton Heart & Vascular Institute is currently participating in the Shockwave C2+ 2Hz Coronary IVL Catheter in Calcified Coronary Arteries study, looking at Shockwave coronary intravascular lithotripsy (IVL). The institute also participated in the PRECISE trial looking at the comparative effectiveness of diagnostic evaluation strategies for stable coronary artery disease, and the REVEALPLAQUE study, which collected data for the next major update in guidelines for coronary artery disease.