Contemporary Clinical Trials Communications (Dec 2022)
Effect of perioperative intravenous amiodarone on cardioversion of atrial fibrillation early after video-assisted thoracoscopic surgical ablation: Study protocol for a double-blind randomized controlled trial
Abstract
Introduction: Video-assisted thoracoscopic surgical (VATS) ablation is widely performed in surgical areas to treat atrial fibrillation (AF), which is minimally invasive and highly effective. Amiodarone, known as a class III antiarrhythmic agent, has the greatest potential to maintain sinus rhythm of AF. At present, few studies focused on the efficacy of perioperative intravenous amiodarone in the VATS ablation of AF. Therefore, the trial is designed to investigate the effect of perioperative amiodarone infusion on cardioversion of AF early after VATS ablation. Methods: and analysis: This will be a prospective, randomized, double-blind, controlled trial. The trial is to enroll 182 patients aged 18–70 years who will undergo VATS ablation of AF. All eligible participants will be randomly allocated to either the amiodarone or placebo group by using the block randomization in a 1:1 ratio. The primary endpoint will be freedom from atrial arrhythmias 24 h after the VATS procedure and be assessed using the Kaplan-Meier method. All data will be analyzed in accordance with the intention-to-treat principle. Discussion: The clinical trial has been designed to investigate the efficacy of perioperative intravenous amiodarone on cardioversion of AF early after VATS ablation. We are hoping to demonstrate that perioperative infusion of amiodarone could improve the maintenance of sinus rhythm 24 h after VATS ablation.