Girish M Nair1, David H Birnie1, George A Wells1, Pablo B Nery1, Calum J Redpath1, Jean-Francois Sarrazin2, Jean-Francois Roux3, Ratika Parkash4, Martin Bernier5, Laurence D Sterns6, Paul Novak6, George Veenhuyzen7, Carlos A Morillo7, Sheldon M Singh8, Marcio Sturmer9, Vijay S Chauhan10, Paul Angaran11, Vidal Essebag12. 1. University of Ottawa Heart Institute, Ottawa, Canada. 2. IUCPQ, Quebec, Quebec, Canada. 3. CHUS-Sherbrooke, Sherbrooke, Quebec, Canada. 4. Queen Elizabeth II Health Sciences, Halifax, Nova Scotia, Canada. 5. McGill University Health Centre, Montreal, Quebec, Canada. 6. Victoria Cardiac Arrhythmia Trials, Victoria, British Columbia, Canada. 7. Libin Cardiovascular Institute, University of Calgary, Calgary, Alberta, Canada. 8. Sunnybrook Health Sciences Center, Toronto, Ontario, Canada. 9. Hôpital Sacré-Cœur de Montréal, Montréal, Québec, Canada. 10. University Health Network, Toronto General Hospital, Toronto, Ontario, Canada. 11. St. Michael's Hospital, University of Toronto, Toronto, Ontario, Canada. 12. McGill University Health Centre, Montreal, Quebec, Canada; Hôpital Sacré-Cœur de Montréal, Montréal, Québec, Canada.
Abstract
BACKGROUND: Recurrence of atrial fibrillation (AF) after a pulmonary vein isolation procedure is often due to electrical reconnection of the pulmonary veins. Repeat ablation procedures may improve freedom from AF but are associated with increased risks and health care costs. A novel ablation strategy in which patients receive "augmented" ablation lesions has the potential to reduce the risk of AF recurrence. OBJECTIVE: The Augmented Wide Area Circumferential Catheter Ablation for Reduction of Atrial Fibrillation Recurrence (AWARE) Trial was designed to evaluate whether an augmented wide-area circumferential antral (WACA) ablation strategy will result in fewer atrial arrhythmia recurrences in patients with symptomatic paroxysmal AF, compared with a conventional WACA strategy. METHODS/ DESIGN: The AWARE trial was a multicenter, prospective, randomized, open, blinded endpoint trial that has completed recruitment (ClinicalTrials.gov NCT02150902). Patients were randomly assigned (1:1) to either the control arm (single WACAlesion set) or the interventional arm (augmented- double WACA lesion set performed after the initial WACA). The primary outcome was atrial tachyarrhythmia (AA; atrial tachycardia [AT], atrial flutter [AFl] or AF) recurrence between days 91 and 365 post catheter ablation. Patient follow-up included 14-day continuous ambulatory ECG monitoring at 3, 6, and 12 months after catheter ablation. Three questionnaires were administered during the trial- the EuroQuol-5D (EQ-5D) quality of life scale, the Canadian Cardiovascular Society Severity of Atrial Fibrillation scale, and a patient satisfaction scale. DISCUSSION: The AWARE trial was designed to evaluate whether a novel approach to catheter ablation reduced the risk of AA recurrence in patients with symptomatic paroxysmal AF.
BACKGROUND: Recurrence of atrial fibrillation (AF) after a pulmonary vein isolation procedure is often due to electrical reconnection of the pulmonary veins. Repeat ablation procedures may improve freedom from AF but are associated with increased risks and health care costs. A novel ablation strategy in which patients receive "augmented" ablation lesions has the potential to reduce the risk of AF recurrence. OBJECTIVE: The Augmented Wide Area Circumferential Catheter Ablation for Reduction of Atrial Fibrillation Recurrence (AWARE) Trial was designed to evaluate whether an augmented wide-area circumferential antral (WACA) ablation strategy will result in fewer atrial arrhythmia recurrences in patients with symptomatic paroxysmal AF, compared with a conventional WACA strategy. METHODS/ DESIGN: The AWARE trial was a multicenter, prospective, randomized, open, blinded endpoint trial that has completed recruitment (ClinicalTrials.gov NCT02150902). Patients were randomly assigned (1:1) to either the control arm (single WACAlesion set) or the interventional arm (augmented- double WACA lesion set performed after the initial WACA). The primary outcome was atrial tachyarrhythmia (AA; atrial tachycardia [AT], atrial flutter [AFl] or AF) recurrence between days 91 and 365 post catheter ablation. Patient follow-up included 14-day continuous ambulatory ECG monitoring at 3, 6, and 12 months after catheter ablation. Three questionnaires were administered during the trial- the EuroQuol-5D (EQ-5D) quality of life scale, the Canadian Cardiovascular Society Severity of Atrial Fibrillation scale, and a patient satisfaction scale. DISCUSSION: The AWARE trial was designed to evaluate whether a novel approach to catheter ablation reduced the risk of AA recurrence in patients with symptomatic paroxysmal AF.
Authors: Youzheng Dong; Shucai Xiao; Jinwu He; Kaixin Shi; Si Chen; Deping Liu; Bin Huang; Zhenyu Zhai; Juxiang Li Journal: Front Cardiovasc Med Date: 2022-08-04