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

Inclusion Criteria:

• Subject aged 20-85 years old.

• Patients able to provide written informed consent, understand, and be willing tocomply with study-related procedures.

• Participants who are scheduled to undergo open-chest cardiac surgery via completemedian sternotomy. Includes:

• Coronary artery bypass graft (CABG) and/or valve repair/replacement procedures (aortic, mitral, or tricuspid)

• Isolated ascending aortic aneurysm replacement/repair

• Note: Left atrial appendage (LAA) procedures are allowed if CABG and/or valverepair or replacement is the qualifying surgical procedure, but is not aqualifying surgical procedure on its own.

• In sinus rhythm at the time of office visit and prior electrocardiogram (EKG) (note:continuous EKG monitoring for 48 hours is not required).

Exclusion Criteria:

• Subject unable to give voluntary written informed consent, is unlikely to cooperateor is legally incompetent, including subjects who are institutionalized by court orofficial order, or in a dependency relationship with, testing center orinvestigator.

• Any condition which could interfere with the subject's ability to comply with thestudy.

• Ongoing participation in an interventional clinical study or during the preceding 30days.

• Female subjects who are pregnant, breastfeeding, were pregnant within the last threemonths, or are planning to become pregnant during the course of the study.

• Active skin or deep infection at the site of implantation.

• History of chronic wounds or wound-healing disorders.

• Known connective tissue diseases (e.g. Ehlers-Danlos syndrome, Epidermolysisbullosa, Marfan syndrome, Osteogenesis imperfecta).

• Immune-suppressed subjects, immune-deficiency subjects (properly managed diabetesmellitus is not an exclusion criterion).

• Concomitant oral or IV systemic corticosteroid therapy and/or other constantanti-inflammatory therapies.

• Patients already receiving amiodarone as a treatment for atrial fibrillation orventricular arrhythmias.

• Disease of the left pleura, previous intervention in the left pleural space, orchest deformity.

• Subjects with end-stage chronic-renal disease / dialysis.

• STS (Society of Thoracic Surgeons Score) risk score >5.5% for 30 day mortality.