Evaluation Of New Onset Postoperative Atrial Fibrillation

The objective of this prospective clinical trial is to demonstrate the safety and efficacy
of the CorMatrix ECM for Pericardial Closure to reduce the incidence of new onset
postoperative atrial fibrillation by circumferentially reconstructing the normal pericardial
anatomy following isolated, first-time, coronary artery bypass grafting (CABG) procedures as
compared to subjects who did not undergo pericardial closure. Safety will be established by
demonstrating that the composite clinical event rate for the ECM treatment group is not
worse than the control group that did not undergo pericardial closure. The efficacy will be
established by demonstrating a reduced incidence of new onset postoperative atrial
fibrillation in the ECM treatment group as compared to the control group.

Inclusion Criteria:

- The subject is 18 years of age or older

- This cardiac operation is the subject's first or primary cardiac operation

- The subject must be undergoing an isolated CABG procedure using a median sternotomy
approach

- The subject must possess the ability to provide written Informed Consent

- The subject must express a willingness to fulfill all of the expected requirements of
this clinical protocol

Exclusion Criteria:

- Prior history of atrial fibrillation

- Prior history of open heart surgery

- Prior history of pericarditis

- Prior history of anti-arrhythmia drug treatment (e.g., amiodarone, dronedarone or
sotalol) in the past six months

- The subject has an implantable cardiac device (i.e., cardiac resynchronization
therapy devices with and without defibrillator capabilities (CRTs and CRT-Ds),
implantable cardioverter-defibrillators (ICD) and pacemakers)

- Concomitant procedure planned

- In the investigator's opinion, the subject may require prophylactic treatment with
anti-arrhythmia drugs or temporary pacing postoperatively