A streamlined AF ablation procedure done without PV mapping as a daycase is more effective than anti-arrhythmic drugs at reducing all hospital episodes for recurrent atrial fibrillation.
AVATAR-AF is a multicentre, randomised controlled study comparing a streamlined AVATAR-protocol ablation procedure to anti-arrhythmic therapy in patients with documented paroxysmal AF who are considered to be failing current strategy for AF. A secondary control arm will also compare the AVATAR-protocol to conventional AF ablation. 300 patients who are on no prior anti-arrhythmic, 'pill-in-pocket' or taking regular anti-arrhythmics will be randomised in a 1:1:1 manner to a treatment strategy of either AVATAR-protocol ablation, anti-arrhythmic therapy or conventional AF ablation and followed-up for 1 year.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
321
Experimental ablation protocol
Group 2 will be prescribed medication listed below: Amiodarone; Dronaderone; Sotalol Beta blockers; Calcium channel blockers; Flecainide; or Propafenone. You will then be discharged from clinic. A research nurse will contact you by phone to make sure there are no problems and can make hospital appointments if needed.
Conventional ablation procedure
The Royal Bournemouth Hospital
Bournemouth, United Kingdom
Brighton University Hospital
Brighton, United Kingdom
Coventry University Hospital
Coventry, United Kingdom
All Hospital Episodes (Emergency Room or Patient Request for OPD) Related to Treatment for Atrial Arrhythmia
Composite outcome measure - Hospital episodes (Emergency Room or Patient Request for OPD) Related to Treatment for Atrial Arrhythmia
Time frame: 12 months
Death or Stroke From Any Cause
Composite outcome measure
Time frame: 12 months
Any Complications Caused by the Procedure (Pericardial Effusion, Bleeding >2 Units, Phrenic Nerve Palsy and Other) or the Anti-arrhythmic Drug (GI Disturbance, Skin Irritation and Other)
Composite outcome measure - Caused by the Procedure (Pericardial Effusion, Bleeding \>2 Units, Phrenic Nerve Palsy and Other) or the Anti-arrhythmic Drug (GI Disturbance, Skin Irritation and Other)
Time frame: 12 months
All Hospital Episodes Which Result in a Change in Therapy for Atrial Arrhythmia
Composite outcome measure - All hospital episodes which result in a change in therapy for atrial arrhythmia
Time frame: 12 months
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Eastbourne District General Hospital
Eastbourne, United Kingdom
Castle Hill Hospital
Hull, United Kingdom
Leeds General Infirmary
Leeds, United Kingdom
Liverpool Heart and Chest Hospital
Liverpool, United Kingdom
St Bartholomew's Hospital
London, United Kingdom
Hammersmith Hospital
London, United Kingdom
Freeman Hospital
Newcastle, United Kingdom
...and 3 more locations