Effect of DrOnedarone on atrial fibrosis progression and atrial fibrillation recurrence postablation: Design of the EDORA randomized clinical trial

Nassir F Marrouche, Lilas Dagher, Oussama Wazni, Nazem Akoum, Moussa Mansour, Abdel Hadi El Hajjar, Arezu Bhatnagar, He Hua, EDORA Investigators, Nassir F Marrouche, Lilas Dagher, Oussama Wazni, Nazem Akoum, Moussa Mansour, Abdel Hadi El Hajjar, Arezu Bhatnagar, He Hua, EDORA Investigators

Abstract

Background: Atrial fibrillation (AF) recurrence after catheter ablation is associated with worse outcomes and quality of life. Left atrial (LA) structural remodeling provides the essential substrate for AF perpetuation. Baseline extent and the progression of LA fibrosis after ablation are strong predictors of postprocedural AF recurrence. Dronedarone is an antiarrhythmic drug proven to efficiently maintain sinus rhythm.

Objective: We sought to investigate the effect of the antiarrhythmic drug Dronedarone in decreasing LA fibrosis progression and AF recurrence after ablation of AF patients.

Methods: EDORA (NCT04704050) is a multicenter, prospective, randomized controlled clinical trial. Patients with persistent or paroxysmal AF undergoing AF ablation will be randomized into Dronedarone versus placebo/standard of care. The co-primary outcomes are the recurrence of atrial arrhythmias (AA) within 13 months of follow-up after ablation and the progression of left atrial fibrosis postablation. All patients will receive a late-gadolinium enhancement magnetic resonance imaging at baseline, 3- and 12-month follow-up for the quantification of LA fibrosis and ablation-related scarring. AA recurrence and burden will be assessed using a 30-day ECG patch every 3 months with daily ECG recordings in between. Quality of life improvement is assessed using the AFEQT and AFSS questionnaires.

Conclusion: EDORA will be the first trial to assess the progression of LA structural remodeling after ablation and its association with Dronedarone treatment and ablation success in a randomized controlled fashion. The trial will provide insight into the pathophysiology of AF recurrence after ablation and may provide potential therapeutic targets to optimize procedural outcomes.

Keywords: ablation; atrial fibrillation; dronedarone; fibrosis.

Conflict of interest statement

Dr. Marrouche reports having received consulting fees from Biosense Webster, as well as research funding from Biosense Webster, Abbot, Medtronic, and Boston Scientific. Dr. Wazni reports receiving consultant fees from Boston Scientific, Medtronic, Biosense Webster. All other authors report no conflict of interest.

© 2021 The Authors. Journal of Cardiovascular Electrophysiology Published by Wiley Periodicals LLC.

Figures

Figure 1
Figure 1
EDORA design flowchart. AA, atrial arrhythmia; AF, atrial fibrillation, LGE‐MRI, late gadolinium enhancement magnetic resonance imaging, SOC, standard of care
Figure 2
Figure 2
Follow‐up design for the EDORA trial. AFEQT, atrial fibrillation effect on QualiTy‐of‐life, AFSS, Atrial Fibrillation Severity Scale; MRI, magnetic resonance imaging

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