Safety and Efficacy Study of Amniotic Membrane Patch to Treat Postoperative Atrial Fibrillation

New onset postoperative atrial fibrillation (NOPAF) presents in approximately 27 to 40% of
patients who have recently undergone coronary artery bypass graft (CABG) or other open heart
surgeries. NOPAF can put patients at clinical risk for stroke and other arrhythmias. NOPAF
commonly prolongs hospitalization leading to increased use of hospital resources, higher
cost and decreased patient satisfaction. A number of risk factors have been associated with
the development of NOPAF including age, prior history of atrial fibrillation, Chronic
Obstructive Pulmonary Disease (COPD), chronic renal failure, diabetes and obesity. It is not
entirely clear what causes NOPAF; the prevailing theory is that it is a multi-factorial
process, possibly due in part to inflammation from the surgery. The usual treatments for
NOPAF are associated with various side effects and risks. We propose to test the hypothesis
that an amniotic membrane patch, with minimal known risk and side effects, placed on the
heart's surface during surgery will reduce the incidence of NOPAF.

This phase I/II prospective, single-center, randomized controlled clinical trial is being
undertaken to assess the safety of the amniotic membrane patch when used in the setting of
CABG surgery and whether utilization of the amniotic membrane patch to aid repair of the
normal epicardium following isolated, first-time CABG procedures might result in a lower
rate of NOPAF compared to subjects who did not undergo treatment with the amniotic membrane
patch.

Inclusion Criteria:

- 18 years 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

- Must have ability to provide written informed consent

- Must have ability to fulfill all of the expected requirements of this clinical
protocol

Preoperative 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

Intraoperative Exclusion Criteria:

- Unexpected procedure (i.e., valve repair/replacement) or intraoperative findings
creating an unreasonable intraoperative risk or an increased probability of
postoperative complications in terms of recovery.

- CABG procedure with > 3 hours total on (cardiopulmonary bypass) CPB.

- Prophylactic use of amiodarone.

Postoperative Exclusion Criteria:

- Prophylactic use of amiodarone

- No prophylactic, temporary pacing except for symptomatic bradycardia or advanced
heart black as defined as:

- Sinus bradycardia < 40 beats per minute

- Type 1 atrioventricular (AV) block

- Type 2 AV block

- Complete block