Study design
Atrial Fibrillation
SECONDARY, ATRIAL FIBRILLATION, EMERGENCY
Ablation Versus Anti-arrhythmic Therapy for Reducing All Hospital Episodes from Recurrent Atrial Fibrillation (AVATAR-AF) was a randomized, multi-centre, open label trial testing superiority of a ‘streamlined’ AVATAR-protocol ablation procedure over drug therapy as the primary hypothesis. An AF specialist confirmed patient suitability for both arms.A core part of clinical AF management is patient education to improve symptom control. This includes understanding that AF will self-terminate and using a ‘pill-in-the-pocket’ if needed. If done properly, the majority of patients with paroxysmal AF will avoid the Emergency Room and hospital admission. However, these episodes will still be debilitating; therefore, it is essential that hospital outpatient episodes are included to capture all patients who continue to suffer significant symptoms from paroxysmal AF. Therefore, we used a primary outcome measure that included outpatient hospital episodes, for patients who are symptomatic and need modification of their AF treatment strategy, as well as those needing emergency care.Confirming PVI is considered essential to the AF ablation procedure. We addressed this as a secondary hypothesis using a second control arm of cryo-balloon AF ablation following standard practice and testing for superiority over the ‘streamlined’ AVATAR approach.The trial was sponsored by Imperial College London (London, UK) and approved by the Health Research Authority [London - Brent Local Research Ethics Committee (14/LO/0117)]. The Trial Steering Committee was responsible for study conduct, oversight, and reporting. The study was adopted onto the National Institute of Health Research Portfolio and received support from the Comprehensive Local Research Network which provided research nurses at each site. An independent Data Safety Monitoring Board ensured optimal therapy was delivered according to protocol. An Endpoints Adjudication Committee was blinded to assigned treatment and used specified definitions to validate all reported endpoints. Trial management, quality control, quality assurance, data management, and statistical analysis were provided by the United Kingdom clinical research collaboration (UKCRC)-registered Imperial Clinical Trials Unit. The rationale and design of the AVATAR-AF study has been published.