Augmented wide area circumferential catheter ablation for reduction of atrial fibrillation recurrence (AWARE) trial: Design and rationale

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 p...

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Bibliographic Details
Published in:The American heart journal 2022-06, Vol.248, p.1-12
Main Authors: Nair, Girish M, Birnie, David H, Wells, George A, Nery, Pablo B, Redpath, Calum J, Sarrazin, Jean-Francois, Roux, Jean-Francois, Parkash, Ratika, Bernier, Martin, Sterns, Laurence D., Novak, Paul, Veenhuyzen, George, Morillo, Carlos A., Singh, Sheldon M., Sturmer, Marcio, Chauhan, Vijay S., Angaran, Paul, Essebag, Vidal
Format: Article
Language:English
Subjects:
Ablation
Adenosine
Arrhythmia
Atrial Fibrillation
Canada
Cardiac arrhythmia
Catheter Ablation - methods
Catheters
Circumferences
Design
EKG
Feasibility studies
Fibrillation
Flutter
Health care
Health risks
Heart
Humans
Lesions
Lungs
Medical instruments
Mortality
Patient satisfaction
Patients
Prospective Studies
Pulmonary Veins - surgery
Quality of Life
Radiofrequency ablation
Recurrence
Reduction
Strategy
Tachyarrhythmia
Tachycardia
Treatment Outcome
Veins & arteries
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Summary: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. 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. 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. 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.
ISSN:0002-8703
1097-6744
DOI:10.1016/j.ahj.2022.02.009