An estimated six and a half million adults in the United States suffer from heart failure, causing those afflicted to experience debilitating symptoms such as persistent exhaustion, trouble breathing, confusion and memory loss. While there have been advancements in treatment and pharmacological therapies, often patients have only a few invasive options, including ventricular devices and heart transplant. Catholic Health’s St. Francis Hospital & Heart Center® is currently the only hospital on Long Island enrolling patients in a new clinical trial to evaluate a first-of-its-kind treatment option for heart failure, having already successfully performed the procedure on one of their patients.
Franklin Square resident, Eugene Roberts, 58, suffers from congestive heart failure and heart disease. He often has trouble breathing, feels weak, and can’t walk long distances. After exhausting all of his non-invasive treatment options, he turned to his long-time St. Francis Cardiologist Rita Jermyn, MD, who suggested he participate in the clinical trial.
“The love for my family and complete trust in Dr. Jermyn ultimately pushed me to participate in the trial,” said Roberts. “I had gone as far as I could with the medication, and wanted to avoid the need for a Left Ventricular Assist Device (LVAD) or heart transplant. My life has been in Dr. Jermyn’s hands for a couple of years now, and I trust that this was the best course of action for my treatment.”
The CORCINCH-HF Study is evaluating the safety and efficacy of the AccuCinch® Ventricular Restoration System, a new and innovative approach to treating heart failure designed to improve the structure and function of the heart and help reduce symptoms, improve quality of life and potentially increase life expectancy.
Like Roberts, about half of heart failure patients have an enlarged left ventricle, the main pumping chamber of the heart, which causes more stress on the heart and leads to reduced pumping efficiency (called ejection fraction). Up to 50 percent of people who develop heart failure die within 5 years of diagnosis. Because heart failure is progressive, meaning symptoms tend to worsen over time, patients need new options when existing therapies are no longer able to manage their condition. Early clinical data suggests the AccuCinch System may address this need in patients who have heart failure with reduced ejection fraction (HFrEF), possibly providing a new option that improves heart function and slows disease progression.
“We believe there is an unmet need in the treatment of heart failure patients with symptoms that make the activities of their daily lives challenging,” said St. Francis Director of Interventional Cardiovascular Procedures and Co-Director of the Heart Valve Center George A. Petrossian, MD. “Dr. William Chung and I are excited to have treated Mr. Roberts with the CORCINCH-HF trial and look forward to determining the role of this exciting therapy.”
During the minimally invasive AccuCinch procedure, a flexible implant is attached to the interior of the 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.
“St. Francis is honored to always bring our patients the latest and most innovative developments in the field of cardiovascular medicine,” said St. Francis President Charles L. Lucore, MD, MBA. “We are excited by the prospects of this procedure and hope it offer some relief to those whose everyday lives are affected by heart failure.”
About The CORCINCH-HF Study and the AccuCinch System
The CORCINCH-HF Study includes heart centers from around the world, including Catholic Health’s St. Francis Hospital & Heart Center®. The study will enroll 400 patients as part of a regulatory process to gain approval from the FDA to sell the AccuCinch System in the U.S. 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:
- Have been told they have heart failure by their doctor
- Have had their doctor explain that they have reduced ejection fraction (low heart pumping ability)
- Are taking heart failure medications, but have symptoms that are worsening (e.g., shortness of breath, fatigue, coughing, leg swelling, or trouble breathing at night)
The AccuCinch System is an investigational device currently being evaluated in multiple clinical trials. Early clinical data suggests that the system may provide an effective treatment option by filling the gap between medication or cardiac resynchronization therapy and left ventricular assist devices (LVADs) or a heart transplant. The AccuCinch System was developed by Santa Clara, California-based Ancora Heart.
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