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

The purpose of this study is to determine the safety of a drug-device treatment for the prevention of postoperative atrial fibrillation following open heart surgery. Approximately a quarter of patients will develop atrial fibrillation after open heart surgery. Atrial fibrillation is a type of irregular heart rhythm or arrhythmia, in which the heart does not pump effectively. This can lead to problems such as stroke, palpitations (an abnormal heart rhythm that can feel like your heart is racing or pounding) and prolonged hospital stays. The goal of this study is to determine if the application of a medication (amiodarone) containing patch on the surface of the heart at the time of surgery is safe, which may lead to a treatment to lower the rate of atrial fibrillation in patients undergoing open heart surgery. The study drug-device is not yet FDA approved.

Inclusion criteria

• Subjects 20-85 years old.
• Subjects able to give voluntary written informed consent, who understand and are willing to comply with study-related procedures.
• Subjects scheduled to undergo open-chest cardiac surgery via complete median sternotomy.
• 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 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.