CorMatrix Cardiovascular has announced preliminary results of its New Onset Post-Operative Atrial Fibrillation clinical trial. The randomised, prospective trial evaluated the use of CorMatrix ECM to close the pericardium of patients undergoing first-time coronary artery bypass grafting (CABG) at 15 US clinical sites by examining post-operative clinical outcomes and the incidence of selected complications. More than 400 patients participated in the study and were randomly assigned either to have their pericardium closed with CorMatrix ECM or to have their pericardium left open following CABG surgery.
The study met its primary and secondary safety endpoints related to the use of CorMatrix ECM to close the pericardium. In addition, the study demonstrated that the ECM technology does not increase the incidence of cardiac tamponade and does not cause bypass grafts to ‘kink’ and close postoperatively. Results regarding new onset of postoperative atrial fibrillation, the primary effectiveness endpoint of the trial, did not show a statistically significant difference between the treatment and control groups. Statisticians and physician consultants will continue to study the extensive data to identify any patient or surgical technique factors that may impact patient outcomes.
Although cardiac surgeons understand the benefit of closing the pericardium to avoid injury of the heart when they are required to perform second operations, which currently represents one in five cardiac surgical procedures, many surgeons are hesitant to close the pericardium for fear that immediate postoperative cardiac bleeding might compress the heart.
The study found there was no significant difference in the incidence of cardiac tamponade when using CorMatrix ECM to form a water-tight seal of the pericardium following cardiac surgery.
Moreover, concerns that closing the pericardium could cause coronary bypass grafts to ‘kink’ and close postoperatively were also found to be unwarranted. The study found there was no significant difference in the incidence of graft occlusion when using CorMatrix ECM technology, providing another important safety assurance for surgeons.
“We are highly encouraged by the study’s excellent safety results and by the growing acceptance of this regenerative technology in the marketplace,” said David B Camp, chairman and CEO of CorMatrix. “We will continue to evaluate the clinical trial data to better understand the factors that may affect postoperative atrial fibrillation.”
CorMatrix ECM is a naturally-occurring extracellular matrix biomaterial that supports native tissue repair by enabling a patient’s own cells to repopulate and repair damaged tissues.