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

Exclusion Criteria

• •Subjects unable to give voluntary written informed consent, unlikely to cooperate, or legally incompetent, including subjects institutionalized by court or official order, or in a dependency relationship with testing center or investigator.
• •Subjects with a condition that could interfere with their ability to comply with the study.
• •Subjects participating in an interventional clinical study or who have participated in such study 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 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 managed diabetes mellitus is not an exclusion criterion).
• •Subjects on concomitant oral or IV systemic corticosteroid therapy and/or other constant 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 including dofetilide, dronedarone, ibutilide and vernakalant.
• •Subjects with coadministration of any medications which cause QT prolongation
• •Subjects with implantable cardiac devices (i.e., cardiac resynchronization therapy devices with and without defibrillator capabilities (CRTs and CRT-Ds), implantable cardioverter-defibrillators (ICD), and pacemakers).
• •Subjects with a known history of atrial fibrillation or paroxysmal atrial fibrillation.
• •Subjects with a history of ablation for atrial fibrillation.
• •Subjects already receiving amiodarone as a treatment for atrial fibrillation or ventricular arrhythmias.
• •Subjects with a disease of the left pleura, previous intervention in the left pleural space, or chest deformity.
• •Subjects with heart failure (BNP\>1000), low ejection fraction (\<35%), end-stage renal disease (on dialysis or GFR\<20).
• •Subjects electing to receive an ablative procedure for atrial fibrillation during the index operation.
• •Subjects with prior cardiac surgery via sternotomy.