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ClinicalTrials.gov·

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

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).

Company
China National Center for Cardiovascular Diseases
Keywords
Atrial Fibrillation (AF), atrial fibrillation, pulsed field ablation, deep sedation