Amiodarone-Infused CardiaMend Patches for the Prevention of New-Onset POAF in Cardiac Surgery Subjects

Inclusion Criteria:

• Subjects 20-85 years old.

• Subjects able to give voluntary written informed consent, who understand and arewilling to comply with study-related procedures.

• Subjects scheduled to undergo open-chest cardiac surgery via complete mediansternotomy.

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

Exclusion Criteria:

• Subjects unable to give voluntary written informed consent, unlikely to cooperate,or legally incompetent, including subjects institutionalized by court or officialorder, or in a dependency relationship with testing center or investigator.

• Subjects with a condition that could interfere with their ability to comply with thestudy.

• Subjects participating in an interventional clinical study or who have participatedin such study during the preceding 30 days.

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

• Subjects with active skin or deep infection at the site of implantation.

• Subjects with a history of chronic wounds or wound-healing disorders.

• Subjects with known connective tissue diseases (e.g. Ehlers-Danlos syndrome,Epidermolysis bullosa, Marfan syndrome, Osteogenesis imperfecta).

• Subjects who are Immune-suppressed or with immune deficiency (properly manageddiabetes mellitus is not an exclusion criterion).

• Subjects on concomitant oral or IV systemic corticosteroid therapy and/or otherconstant anti-inflammatory therapies.

• Subjects on the following medications with known interactions with amiodarone:doxorubicin, fosphenytoin, lopinavir-ritonavir, ledipasvir/sofosbuvir, quinidine ,procainamide, disopyramide, other Vaughan William class III agents includingdofetilide, dronedarone, ibutilide and vernakalant.

• Subjects with coadministration of any medications which cause QT prolongation

• Subjects with implantable cardiac devices (i.e., cardiac resynchronization therapydevices with and without defibrillator capabilities (CRTs and CRT-Ds), implantablecardioverter-defibrillators (ICD), and pacemakers).

• Subjects with a known history of atrial fibrillation or paroxysmal atrialfibrillation.

• Subjects with a history of ablation for atrial fibrillation.

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

• Subjects with a disease of the left pleura, previous intervention in the leftpleural space, or chest deformity.

• Subjects with heart failure (BNP>1000), low ejection fraction (<35%), end-stagerenal disease (on dialysis or GFR<20).

• Subjects electing to receive an ablative procedure for atrial fibrillation duringthe index operation.

• Subjects with prior cardiac surgery via sternotomy.