First Patient Enrolled in Multi-Center Clinical Trial of the CorMatrixÃ‚® ECMÃ‚® for Pericardial Closure to Reduce the Incidence of New Onset Postoperative Atrial Fibrillation
ATLANTA, Dec. 13, 2010 /PRNewswire/ -- CorMatrix Cardiovascular, Inc., an Atlanta-based company dedicated to developing and delivering unique extracellular matrix (ECM) biomaterial devices that harness the body's innate ability to repair damaged cardiovascular tissue, announced today that Franciscan Alliance/St. Francis Heart Center in Indianapolis, Indiana is the first site to enroll a patient in the multi-center clinical trial of the CorMatrix ECM for Pericardial Closure to reduce the incidence of new onset postoperative atrial fibrillation.
This prospective randomized controlled trial will enroll more than 400 patients in up to 15 trial sites across the U.S. The trial will assess the incidence of new onset postoperative atrial fibrillation in patients who undergo primary isolated coronary artery bypass grafting (CABG) and pericardial reconstruction using CorMatrix ECM, versus a control group of CABG patients for whom the pericardium will not be closed.
"CorMatrix is excited to initiate this study of pericardial reconstruction and looks forward to future studies that will explore the many potential uses of the CorMatrix ECM Technology," said Robert Matheny, MD, Chief Scientific Officer at CorMatrix. "We hope this clinical trial will stimulate interest within the healthcare community on the unique advantages of ECM technology and the future of remodeling cardiac tissue."
In October, results were published on a retrospective study of 222 patients comparing the incidence of new onset postoperative atrial fibrillation in primary isolated CABG patients who did and did not receive pericardial closure using CorMatrix ECM. Clinical outcomes of the 111 patients implanted with the CorMatrix ECM showed that new onset postoperative atrial fibrillation occurred in only 20 of 111 treated patients compared to 43 of 111 control patients, representing a 54% reduction in relative risk in the treatment group (P < 0.001).