A randomized clinical trial of early invasive intervention for atrial fibrillation (EARLY-AF) - methods and rationale.

BACKGROUND: The ideal management of patients with newly diagnosed symptomatic atrial fibrillation (AF) remains unknown. Current practice guidelines recommend a trial of antiarrhythmic drugs (AAD) prior to considering an invasive ablation procedure. However, earlier ablation offers an opportunity to halt the progressive patho-anatomical changes associated with AF, as well as impart other important clinical benefits.

OBJECTIVE: The aim of this study is to determine the optimal initial management strategy for patients with newly diagnosed, symptomatic atrial fibrillation.

METHODS/DESIGN: The EARLY-AF study (ClinicalTrials.govNCT02825979) is a prospective, open label, multicenter, randomized trial with a blinded assessment of outcomes. A total of 298 patients will be randomized in a 1:1 fashion to first-line AAD therapy, or first-line cryoballoon-based pulmonary vein isolation. Patients with symptomatic treatment naïve AF will be included. Arrhythmia outcomes will be assessed by implantable cardiac monitor (ICM). The primary outcome is time to first recurrence of AF, atrial flutter, or atrial tachycardia (AF/AFL/AT) between days 91 and 365 following AAD initiation or AF ablation. Secondary outcomes include arrhythmia burden, quality of life, and healthcare utilization.

DISCUSSION: The EARLY-AF study is a randomized trial designed to evaluate the optimal first management approach for patients with AF. We hypothesize that catheter ablation will be superior to drug therapy in prevention of AF recurrence.