The effect of dronaderone on atrial fibrosis and atrial fibrillation recurrence post-ablation

Primary Objective

Purpose: Determine whether dronedarone is effective in slowing the progression of fibrosis and decreasing atrial arrhythmia (AA) recurrence (atrial fibrillation, atrial flutter, or atrial tachycardia) in patients who have undergone AF ablation therapy. Aim 1: Determine if dronedarone reduces post-ablation incidences of atrial arrythmia recurrence compared to placebo. Aim 2: Determine whether dronedarone is effective in slowing down the progression of fibrosis after ablation compared to SOC alone.

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Description

EDORA is a multicenter, prospective, phase IV, randomized, and single-blinded clinical trial

Details
Age

Adult

Eligibility

Patients must meet the following criteria to be enrolled in the trial: 1. Male or female patients aged > 18 years. 2. Patients diagnosed with paroxysmal or persistent AF (evidenced by ECG rhythm strip evaluations or written documentation) and who are undergoing ablation of atrial fibrillation, regardless of whether they were receiving an AAD before enrollment or not.

Patients must meet the following criteria to be enrolled in the trial: 1. Male or female patients aged > 18 years. 2. Patients diagnosed with paroxysmal or persistent AF (evidenced by ECG rhythm strip evaluations or written documentation) and who are undergoing ablation of atrial fibrillation, regardless of whether they were receiving an AAD before enrollment or not.

Type of Study

Treatment

Scope

National

Locations

Memorial Hospital Central

Study ID

Protocol Number: 21-3993

More information available at ClinicalTrials.gov: NCT04704050

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