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

Prior treatment

• Concomitant oral or IV systemic corticosteroid therapy and/or other constant anti-inflammatory therapies.
• Patients already receiving amiodarone as a treatment for atrial fibrillation or ventricular arrhythmias.
• Disease of the left pleura, previous intervention in the left pleural space, or chest deformity.

Other illness

• Any condition which could interfere with the subject's ability to comply with 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, Epidermolysis bullosa, Marfan syndrome, Osteogenesis imperfecta).
• Immune-suppressed subjects, immune-deficiency subjects (properly managed diabetes mellitus is not an exclusion criterion).
• Subjects with end-stage chronic-renal disease / dialysis.

Other

• Subject unable to give voluntary written informed consent, is unlikely to cooperate or is legally incompetent, including subjects who are institutionalized by court or official order, or in a dependency relationship with, testing center or investigator.
• Ongoing participation in an interventional clinical study or during the preceding 30 days.
• Female subjects who are pregnant, breastfeeding, were pregnant within the last three months, or are planning to become pregnant during the course of the study.
• STS (Society of Thoracic Surgeons Score) risk score \>5.5% for 30 day mortality.

• Subject aged 20-85 years old.
• Patients able to provide written informed consent, understand, and be willing to comply with study-related procedures.
• Participants who are scheduled to undergo open-chest cardiac surgery via complete median 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 valve repair or replacement is the qualifying surgical procedure, but is not a qualifying 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).