The Christ Hospital Heart & Vascular Institute Announces Participation in Global Clinical Trail for New Heart Failure Treatment
First in Cincinnati Region to Enroll Patients in Pivotal Study Evaluating New Minimally Invasive Therapy
7/20/2021
The Christ Hospital Heart & Vascular Institute today announced it is the first in the Greater Cincinnati Region to begin enrolling patients in a new clinical trial to evaluate a first-of-its-kind treatment option for heart failure. 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 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.
"Even when a heart failure patient and their doctors do everything right, as the disease progresses, an active life becomes more challenging," said Eugene S. Chung, M.D., Advanced Heart Failure Cardiologist at The Christ Hospital. "Clinical research options are always something we think about when someone has the ambition in life to be more active than heart failure enables them to be."
An estimated 6.5 million U.S. adults live with heart failure, a condition in which the heart’s muscles weaken and lose their ability to pump enough oxygen-rich blood to the body. 1 Heart failure patients suffer from debilitating symptoms including persistent exhaustion, trouble breathing, confusion and loss of memory. 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 five years of diagnosis. 2
Standard treatment options for heart failure include lifestyle changes, medications, and implanting a pacemaker to help support the heart’s pumping abilities (called cardiac resynchronization therapy). 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.
Timothy Raymond, D.O., FACC, Advanced Heart Failure Cardiology Specialist for The Christ Hospital, explains that medicines and devices to treat enlarged hearts are based on the premise that if you shrink the heart, or “reverse remodel the heart,” patients will feel better and live longer.
AccuCinch is based on that approach.
“This device is shaped like a horseshoe, with hooks spaced out—kind of like fishhooks,” he said. “The hooks implant the device inside the wall of the heart, and a threaded string, similar to a belt through belt loops, is designed to cinch and shrink the heart, allowing it to pump more efficiently and effectively.”
This device is one of the many interventional procedures and technologies, medicines, and surgical options employed by the cardiologists at The Christ Hospital Heart & Vascular Institute. Research opportunities through The Christ Hospital Lindner Center offer cardiology patients a multitude of innovations not offered at other facilities regionally and, often, nationally.
“Heart failure is not about dying early, it’s about not being able to live the best possible version of yourself,” said Dr. Satya Shreenivas, Interventional Cardiologist at The Christ Hospital Lindner Center for Clinical Research. "We are ultimately working to restore health, and the goal is to always repair a heart in the least invasive way possible.”
Thousands of patients from Cincinnati and beyond visit The Christ Hospital annually for heart care. To schedule an appointment, call 513-206-1180 for availability at The Christ Hospital’s Heart & Vascular locations throughout the Tristate.
About The Christ Hospital Health Network
The Christ Hospital Health Network is an acute care hospital located in Mt. Auburn, with a remote hospital location in Liberty Township, five ambulatory outpatient centers, and dozens of offices conveniently located throughout the region. More than 1,300 talented physicians and more than 6,000 dedicated team members support the Network. Its mission is to improve the health of the community and to create patient value by providing exceptional outcomes and the finest experiences, all in an affordable way. The Network has been recognized by U.S. News & World Report as the #1 hospital in the Cincinnati Region and awarded Healthgrades “America’s 50 Best Hospitals” for being in the top 1% in the nation for providing the highest clinical quality year after year. It is also a Press Ganey Guardian of Excellence Award recipient, which recognizes top-performing healthcare organizations that achieve the 95th percentile or above of performance in patient experience. The Christ Hospital is among a select number of hospitals in the nation to be awarded Magnet® recognition for nursing excellence. For more than 130 years, The Christ Hospital has provided compassionate care to those it serves.
About The CORCINCH-HF Study and the AccuCinch System
The CORCINCH-HF Study includes heart centers from around the world, including The Christ Hospital. 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. Additional information is available at www.ancoraheart.com.
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1. Murphy S, Ibrahim N, Januzzi J. Heart Failure with Reduced Ejection Fraction, A Review. JAMA. 2020;324(5):488-504
2. Virani SS, Alonso A, Benjamin EJ, Bittencourt MS, Callaway CW, Carson AP, et al. Heart disease and stroke statistics—2020