From the Emergency Department, Directly to Ablation of Atrial Fibrillation: Rationale and Design of the EMERGE Cryo...

Evidence is limited on an early treatment strategy for any type of recent-onset atrial fibrillation (AF), comparing anti-arrhythmic drug (AAD) therapy to catheter ablation of patients presenting to the emergency department (ED). The purpose of the EMERGE Cryo study is to investigate the impact of early catheter ablation in patients presenting to the ED with recent-onset AF.The EMERGE Cryo study is a prospective, 2-arm, randomized, open-label, blinded endpoint, multicentre study to investigate the impact of first-line ablation vs AAD in patients presenting to the ED (within the preceding 2 weeks) with recent-onset (≤ 1 year) paroxysmal or persistent AF (longest AF episode < 6-month duration). All study participants receive an implantable loop recorder. Randomization is based on a 1:1 ratio into 2 study arms: (i) cryo-AF-ablation: pulmonary vein isolation performed with cryoballoon; and (ii) usual care: AAD therapy, including electrical cardioversion, if necessary. A total of 350 patients will be randomized.Both arms have a blanking period or an AAD optimization period of 3 months, during which adapting the therapy will be allowed. This trial is designed to elaborate whether early AF ablation is superior to usual care. The primary effectiveness endpoint is freedom from any atrial tachyarrhythmia (> 30 seconds) through 3-12 months of follow-up on implantable loop recorder monitoring. Patients will be followed up for 36 months in total.EMERGE Cryo aims to determine the value of early catheter ablation in AF patients presenting with any type of AF to the ED.

NCT05294445.