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

Overview

Journal Clin Cardiol

Specialty Cardiology & Vascular Diseases

Date 2022 Nov 22

PMID 36413635

Authors

Koji Miyamoto

Koshiro Kanaoka

Yasutoshi Ohta

Masue Yoh

Hiroki Takahashi

Rena Tonegawa-Kuji

Yuichiro Miyazaki

Keiko Shimamoto

Akinori Wakamiya

Nobuhiko Ueda

Kenzaburo Nakajima

Tsukasa Kamakura

Mitsuru Wada

Kohei Ishibashi

Yuko Inoue

Satoshi Nagase

Takeshi Aiba

Akihisa Narai

Tomohiro Nakase

Masatoshi Koga

Tetsuya Fukuda

Naoya Kataoka

Masahiko Takagi

Kengo Kusano

Affiliations

Soon will be listed here.

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.

Citing Articles

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.

Miyamoto K, Kanaoka K, Ohta Y, Yoh M, Takahashi H, Tonegawa-Kuji R Clin Cardiol. 2022; 46(2):214-222.

PMID: 36413635 PMC: 9933100. DOI: 10.1002/clc.23949.

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