Aurora St. Luke’s Medical Center in Milwaukee is the first site in Wisconsin to join a clinical trial studying a novel therapy to address heart failure.
The study will evaluate the safety and effectiveness of treatment with the AccuCinch® Ventricular Restoration System in patients with a type of heart failure called heart failure with reduced ejection fraction (HFrEF).
“Patients with this type of heart failure are often treated with medications, however, their heart failure tends to continue to worsen until those medications are no longer effective,” said interventional cardiologist Suhail Allaqaband, MD, Advocate Aurora Research Institute’s site principal investigator for the study. “The AccuCinch device instead aims to address the underlying issue causing HFrEF, which is a dilated, or enlarged, left ventricle, by reshaping the ventricle to improve the heart’s pumping ability.”
Heart failure is a serious condition resulting from permanent damage that impairs the heart’s ability to adequately pump blood with oxygen and nutrients to the rest of the body. More than 6 million Americans are living with heart failure, according to the U.S. Centers for Disease Control and Prevention.
HFrEF is diagnosed by measuring the heart’s ejection fraction, a term that refers to the percentage of blood ejected, or pumped out, from the heart’s left main chamber, or ventricle. In people with HFrEF, the heart’s pumping action is weaker, so a smaller than normal volume of blood is pumped to the rest of the body.
The AccuCinch® Ventricular Restoration System is an investigational device designed to reduce the size of the left ventricle, as well as support and strengthen the heart wall to improve its function. The device is delivered to the heart through a series of flexible tubes, called catheters, that are inserted through a small incision into a blood vessel in the groin and then threaded through the body’s chain of blood vessels. The minimally invasive approach eliminates the need for open heart surgery. Once the AccuCinch® Ventricular Restoration System reaches the heart, it is implanted in a ring around the inner wall of the left ventricle and then cinched, shrinking the size of the chamber.
“As a complement to existing heart failure medications, the AccuCinch device could potentially provide a new, minimally invasive treatment option when medications and pacemaker therapy are no longer effective at managing symptoms but before a left ventricular assist device or heart transplant are needed,” said Laura Wrona, MSN, director of cardiovascular clinical trials research. “Advocate Aurora Health is proud to support clinical research that provides even more treatment options for our patients.”
Researchers across the country plan to enroll 400 participants in the clinical trial. The Research Institute has initially opened the study at Aurora St. Luke’s and plans to expand enrollment to sites in Illinois. Researchers will follow up with participants for up to five years after receiving the device implant.
The study, “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,” is sponsored by Ancora Heart, Inc., manufacturer of the device system.