Study of CardiaMend Patch With Amiodarone to Prevent Atrial Fibrillation After Heart Bypass or Valve Surgery

What this Trial Is About

Researchers are evaluating the use of CardiaMend combined with amiodarone to prevent postoperative atrial fibrillation POAF in adults undergoing cardiac arterial bypass grafting CABG or valve surgery. This prospective randomized study focuses on patients having open-chest surgery via median sternotomy and aims to reduce the occurrence of POAF, a common complication after such surgeries. The study involves applying CardiaMend, a pericardial reconstruction matrix, over the right and left atria after drizzling amiodarone directly onto these areas. The anterior pericardial space is then closed using CardiaMend without pressure on underlying structures. Amiodarone is instilled into the pericardial space to help prevent arrhythmias. The control group receives the University of Chicagos standard care, which includes ligation of the left atrial appendage during surgery and amiodarone injections as applicable. Participants will have continuous electrocardiogram monitoring until hospital discharge, usually lasting about 7 days to 2 weeks. If needed, home monitoring may be provided. Researchers will measure the occurrence of postoperative atrial fibrillation and additional hospital time required due to atrial fibrillation or flutter. The total study participation will last through discharge with ongoing evaluation of amiodarone blood levels in the initial patients to ensure safety.

Prevention of Postoperative Atrial Fibrillation (POAF) Using Intra-Pericardial Amiodarone