The multicenter study, led nationally by principal investigator Marc Gerdisch, M.D., director of cardiovascular surgery at St. Francis, assesses new onset, postoperative atrial fibrillation in patients undergoing primary isolated coronary artery bypass grafting (CABG). The procedure involves the reconstruction of the pericardial sac – the membrane surrounding the heart – using CorMatrix Extracellular Matrix’s (ECM).
"We've 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, M.D., the cardiothoracic surgeon who performed the procedure at St. Francis Hospital-Indianapolis.
"This is a particularly important trial given the clinical and economic implications of new onset postoperative Afib, and we are pleased to have enrolled the first patient,” added Parikshak, who is a trial co-investigator.
ECM is a unique biomaterial device that harnesses the body’s innate ability to repair damaged cardiovascular tissue. ECM is manufactured by Atlanta-based CorMatrix Cardiovascular Inc.
"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, M.D., CorMatrix’s chief scientific officer. "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."
The decellularized matrix material serves as a scaffold to allow adjacent tissues to deliver cells and nutrients to the matrix, which then differentiate into tissue-specific cells. The ECM material is gradually replaced, as the patient's own body reinforces and rebuilds the weakened site.
During the repair, the matrix is naturally degraded and reabsorbed, leaving remodeled functional tissue where scar tissue or injured tissue would normally be expected.
"The unique properties of the CorMatrix ECM provide an excellent opportunity to repair the pericardium and reduce postoperative atrial fibrillation," said Gerdisch. "This trial has the potential to revolutionize treatment options for postoperative Afib patients."
This prospective randomized controlled trial will enroll more than 400 patients in up to 15 trial sites across the
An estimated 2.2 million Americans are said to have Afib, which, if undetected or untreated, can lead to stroke.
This isn’t the first time the St. Francis Heart Center has pioneered the use of ECM technology. In 2008, Gerdisch was the first in the world to successfully use the biomaterial patch in patients with damaged heart valves; he first used the patch in 2007 for intracardial repairs. You can view this work at www.cardiactissuerepair.net.
To learn more about CorMatrix Cardiovascular Inc., go to www.cormatrix.com.
More information about the St. Francis Heart Center and its services can be found at http://stfrancishospitals.org/heart.
