Atlanta-based CorMatrix Cardiovascular, a developer of extracellular matrix (ECM) biomaterial devices to repair damaged cardiovascular tissue, has initiated patient enrollment in multi-center clinical trial of the CorMatrix ECM for pericardial closure to reduce the incidence of new onset postoperative atrial fibrillation (AF).
CorMatrix ECM is a naturally occurring bioscaffold, which helps to 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.
CorMatrix said Franciscan Alliance/St Francis Heart Center in Indianapolis, Indiana is the first site to enroll a patient in the multi-center clinical trial.
The prospective randomised controlled trial will enroll more than 400 patients in up to 15 trial sites across the US and 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 chief scientific officer Robert Matheny said CorMatrix is excited to initiate the study of pericardial reconstruction and looks forward to future studies that will explore the many potential uses of the CorMatrix ECM Technology.
"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," Matheny said.