A randomized clinical trial of early invasive intervention for atrial fibrillation (EARLY-AF) - methods and rationale - 12/12/18
, Jean Champagne, MD c, Marc W. Deyell, MD, MSc b, Vidal Essebag, MD, PhD d, Sandra Lauck, PhD b, Carlos Morillo, MD e, John Sapp, MD f, Alan Skanes, MD g, Patricia Theoret-Patrick, RN, CCRP h, George A. Wells, PhD h, Atul Verma, MD ifor the EARLY-AF Study Investigators
Abstract |
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.gov NCT02825979) 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.
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| Trial Registration number: ClinicalTrials.gov NCT02825979. |
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| Protocol version: 3.0. |
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| Funding source: The EARLY-AF study was funded by a peer-reviewed grant from the Canadian Arrhythmia Network [grant number SRG-15-P15-001], with additional financial support from Medtronic. Drs. Andrade and Deyell are supported by Michael Smith Foundation for Health Research Career Scholar Awards. Dr. Essebag is supported by a Clinical Research Scholar Award from Fonds de recherché du Quebec-Santé (FRQS). All authors are Investigators of the Cardiac Arrhythmia Network of Canada (CANet), a Networks of Centres of Excellence. |
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| Role of the funding source: The funding sources had no role in the design of this study and will not have any role in data collection, study execution, data analyses and interpretation, writing of the report, or decision to submit the report for publication. |
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| Authors contributions: JGA, MWD, GAW, and AV conceived the study, and were involved in the drafting of the peer-reviewed grant, the study protocol, and the manuscript. JC, VE, SL, CM, JS, and AS served on the steering committee for the trial and have provided critical revision of the peer-reviewed grant, the study protocol, and the manuscript. |
Vol 206
P. 94-104 - décembre 2018 Retour au numéro
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