Atlanta (Dec. 20, 2019) — Piedmont Heart Institute is among the first entities in the United States, and the first in Georgia, to begin enrolling patients in a clinical trial evaluating an investigational minimally invasive therapy for heart failure patients who have mitral regurgitation and have had a prior mitral valve intervention. Heart failure is a condition in which the muscles of the heart are weak and lose their ability to adequately pump enough oxygen-rich blood to the body.
The study’s principal local investigator is Pradeep Yadav, M.D. Vivek Rajagopal, M.D., an interventional cardiologist who is Co-Medical Director of the Marcus Heart Valve Center, and Christopher Meduri, M.D., Marcus Chief of Structural and Valvular Heart Disease Therapies at the Marcus Heart Valve Center, are serving as sub-investigators on the trial. The first two procedures in Georgia were performed at Piedmont Atlanta Hospital, representing the third and fourth procedures, respectively, performed in this clinical trial in the United States.
An estimated 6.5 million U.S. adults live with heart failure and suffer from debilitating symptoms including persistent exhaustion, trouble breathing, confusion and loss of memory. There is no cure for heart failure, and up to 50 percent of people who develop heart failure die within five years of diagnosis.
“The AccuCinch System has the potential to be a ground-breaking early treatment option to manage symptoms and slow, or stop, the progression of heart failure,” said Dr. Yadav. “For some patients, initial clinical data suggests AccuCinch may have the potential to reverse the enlargement of the left ventricle. We are excited that Piedmont is participating in this trial as we are committed to helping advance new therapies for the millions of people who suffer from heart failure.”
Ancora Heart’s AccuCinch procedure is the first therapy of its kind designed to repair the left ventricle of the heart directly, to address the fundamental issue in the progression of systolic heart failure. Systolic heart failure is the result of the left ventricle losing its ability to contract normally and the heart is unable to push enough blood to the rest of the body. The minimally invasive procedure is designed to reduce the size of the left ventricle, improve left ventricular function, and reduce symptoms of heart failure, with the goal of improving quality of life for patients.
During the AccuCinch procedure, an implant is placed into the left ventricular wall, just below the mitral valve. Once properly positioned, the implant is then cinched tight and secured in place. Once cinched, the AccuCinch implant is intended to reduce the size of the left ventricle, as well as support and strengthen the heart wall. Early clinical data suggests AccuCinch may address the shortcomings of current heart failure treatments, providing a new option for patients that improves heart function and slows disease progression.