Pulsed Field Ablation for Atrial Fibrillation Under General Anesthesia Versus Remimazolam-based Deep Sedation - NCT07927582

Sponsor: China National Center for Cardiovascular Diseases Conditions: Atrial Fibrillation (AF) Real-world evidence indicates that deep sedation is the predominant anesthesia strategy for pulsed field ablation (PFA) in most European centers, whereas general anesthesia remains the standard of care in China. Given disparities in anesthesiologist availability and fundamental differences in healthcare system infrastructure and workflow organization, establishing an electrophysiologist-led deep sedation pathway has the potential to streamline PFA procedural logistics, enhance perioperative patient comfort, and facilitate the standardized, scalable, and sustainable implementation of this novel technology. This study aims to determine whether pulmonary vein isolation (PVI) performed with PFA under a remimazolam-based deep sedation protocol is non-inferior to PVI under general anesthesia in terms of both safety and efficacy among patients with atrial fibrillation (AF). Eligible patients with atrial fibrillation (AF) will be randomly assigned in a 1:1 ratio, stratified by AF type (paroxysmal vs. persistent), to either the general anesthesia group (GA group) or the deep sedation group (DS group). All participants will undergo bilateral pulmonary vein isolation (PVI) using a pulsed field ablation (PFA) catheter; additional ablation beyond PVI will be performed at the operator's discretion based on procedural assessment. Patients in the GA group will receive general anesthesia per institutional standard of care. Patients in the DS group will receive remimazolam-fentanyl-based deep sedation according to a standardized protocol. Intraoperative monitoring will include continuous 12-lead electrocardiography (ECG), pulse oximetry (SpO₂), and noninvasive arterial blood pressure measurement-at minimum. All participants will undergo a scheduled follow-up visit at 2 months post-procedure.