Jason G Andrade1, Jean Champagne2, Marc W Deyell3, Vidal Essebag4, Sandra Lauck3, Carlos Morillo5, John Sapp6, Alan Skanes7, Patricia Theoret-Patrick8, George A Wells8, Atul Verma9. 1. Montreal Heart Institute, Université de Montréal, Canada; University of British Columbia, Canada. Electronic address: Jason.andrade@vch.ca. 2. Department of Medicine, Université Laval, Quebec, Canada. 3. University of British Columbia, Canada. 4. McGill University Health Centre and Hôpital Sacré-Cœur de Montréal, Montreal, Canada. 5. Department of Cardiac Sciences, University of Calgary, Calgary, Canada. 6. Queen Elizabeth II Health Sciences Centre and Dalhousie University, Halifax, Canada. 7. University of Western Ontario, London, Canada. 8. University of Ottawa Heart Institute, Ottawa, Canada. 9. Southlake Regional Health Center, University of Toronto, Newmarket, Canada.
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.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.
RCT Entities:
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.
Authors: Jason G Andrade; Marc W Deyell; Atul Verma; Laurent Macle; Jean Champagne; Peter Leong-Sit; Paul Novak; Mariano Badra-Verdu; John Sapp; Paul Khairy; Stanley Nattel Journal: JAMA Netw Open Date: 2020-07-01
Authors: Kamala P Tamirisa; Sana M Al-Khatib; Sanghamitra Mohanty; Janet K Han; Andrea Natale; Dhiraj Gupta; Andrea M Russo; Amin Al-Ahmad; Anne M Gillis; Kevin L Thomas Journal: CJC Open Date: 2021-09-13