A multicenter prospective randomized study comparing the incidence of periprocedural cerebral embolisms caused by catheter ablation of atrial fibrillation between cryoballoon and radiofrequency ablation (Embo-Abl study): Study design

Clin Cardiol. 2023 Feb;46(2):214-222. doi: 10.1002/clc.23949. Epub 2022 Nov 22.

Abstract

Background: Although catheter ablation (CA) has become a standard therapeutic approach to atrial fibrillation (AF), it imposes a low but relevant risk of thromboembolic complications of around 0.5%-1%, including ischemic strokes, and has an additional risk of clinically silent cerebral embolisms (SCEs) of 10%-40%. Both cryoballoon (CB) and radiofrequency (RF) ablation are routinely used clinically worldwide, yet there are few prospective data comparing the incidence of cerebral embolism after CA of AF between CB and RF ablation.

Methods: The aim of the Embo-Abl study will be to compare the incidence of cerebral embolisms on 3 T diffusion-weighted image magnetic resonance imaging (MRI) after CA of AF between CB and RF ablation in patients with AF in a prospective, multicenter, open-label, controlled, randomized fashion. The primary endpoint of the Embo-Abl study will be the occurrence of MRI-detected SCE 1-3 days after CA. The patients will be registered and randomly assigned to either the CB or RF ablation group in a 1:1 ratio. The study cohort will include 230 patients with AF from a multicenter in Japan.

Results: The results of this study are currently under investigation.

Conclusion: The Embo-Abl study will be the first to compare the incidence of periprocedural cerebral embolisms caused by CA of AF between CB and RF ablation in a prospective, multicenter, randomized, controlled fashion.

Keywords: atrial fibrillation; cerebral embolism; cryoballoon ablation; radiofrequency ablation.

Publication types

  • Randomized Controlled Trial
  • Multicenter Study

MeSH terms

  • Atrial Fibrillation*
  • Catheter Ablation* / adverse effects
  • Catheter Ablation* / methods
  • Cryosurgery* / adverse effects
  • Cryosurgery* / methods
  • Embolism*
  • Humans
  • Incidence
  • Intracranial Embolism* / diagnosis
  • Intracranial Embolism* / epidemiology
  • Intracranial Embolism* / etiology
  • Prospective Studies
  • Pulmonary Veins* / surgery
  • Recurrence
  • Risk Factors
  • Treatment Outcome

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