CorMatrix Cardiovascular, 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 on 13 December 2010 that Franciscan Alliance/St Francis Heart Center in Indianapolis, Indiana is the first site to enrol a patient in the multicentre clinical trial of the CorMatrix ECM for Pericardial Closure to reduce the incidence of new onset postoperative atrial fibrillation (AF).
This prospective randomised controlled trial will enrol more than 400 patients in up to 15 trial sites across the USA. The trial will assess the incidence of new onset postoperative atrial fibrillation in patients who undergo primary isolated coronary artery bypass grafting and pericardial reconstruction using CorMatrix ECM, versus a control group of bypass grafting 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, 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 coronary artery bypass grafting 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).
“We have seen the significant results of the retrospective study published in Heart Surgery Forum and are encouraged by CorMatrix’s commitment to pursue a prospective trial. We are excited to participate in this study because we believe reconstructing the pericardium with CorMatrix ECM will provide tremendous benefit to our patients,” said Manesh Parikshak, cardiothoracic surgeon at the Franciscan Alliance/St Francis Heart Center, and co-investigator for the trial. “This is a particularly important trial given the clinical and economic implications of new onset postoperative AF, and we are pleased to have enrolled the first patient.”
CorMatrix ECM, a naturally occurring bioscaffold, has been successfully implanted in more than 25,000 patients in the USA. It helps stimulate tissue growth by providing a location where the patient’s cells can migrate and integrate with the ECM, eventually creating new tissue in place of the CorMatrix ECM.
“The unique properties of the CorMatrix ECM provide an excellent opportunity to repair the pericardium and reduce postoperative atrial fibrillation,” said Marc Gerdisch, director of Cardiothoracic Surgery at the Franciscan Alliance/St Francis Heart Center, and overall principal investigator of the trial. “This trial has the potential to revolutionise treatment options for postoperative AF patients.”