BiodEgradable soaked Amiodarone paTch use for the prevention of Atrial Fibrillation after cardiac surgery (The BEAT-AF Trial): Rationale and Design

Postoperative atrial fibrillation (POAF) remains the most common complication following cardiac surgery and contributes substantially to patient morbidity and healthcare utilization. Although amiodarone is among the most effective pharmacologic agents for the prevention and treatment of POAF, its routine use is limited by systemic toxicity and drug interactions. Localized delivery strategies may achieve therapeutic myocardial concentrations while minimizing systemic exposure, but they have never been tested in appropriately powered trials. Experimental studies have indicated that epicardial and intrapericardial administration of amiodarone can reduce atrial vulnerability to tachyarrhythmias while maintaining low circulating drug levels. Preliminary clinical investigations have suggested a potential reduction in POAF incidence with topical amiodarone; however, studies have yielded inconsistent results, leaving uncertainty regarding clinical efficacy. The BiodEgradable soaked Amiodarone paTch use for the prevention of Atrial Fibrillation after cardiac surgery ( BEAT-AF ) trial is a single-center, double-blind, randomized, placebo-controlled trial designed to evaluate the efficacy and safety of topical amiodarone administration for the prevention of POAF following cardiac surgery. A minimum of 500 patients undergoing elective cardiac surgery through median sternotomy will be randomized in a 1:1 ratio to receive either amiodarone-soaked (150 mg/3 mL) or saline-soaked oxidized regenerated cellulose patches applied intra-operatively to the dome of the left atrium and the ostia of the right pulmonary veins immediately prior to sternal closure. The primary outcome is the occurrence of POAF within five days postoperatively. This trial will inform use of topical amiodarone as a strategy for POAF prevention in cardiac surgery patients. NCT06722196.