Ablation Verses Anti-arrhythmic Therapy for Reducing All Hospital Episodes From 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.

Inclusion criteria

• Documented paroxysmal atrial fibrillation
• Modification or initiation of anti-arrhythmic agent required for symptom control
• Males or females eighteen (18) to eighty (80) years of age
• Suitable candidate for catheter ablation
• Signed informed consent

Exclusion criteria

• Contraindication to catheter ablation
• No carer to enable daycase discharge
• Arrhythmias other than AF documented unless they have had curative ablation (eg. for atrial flutter)
• No documentation of sinus rhythm within 3 months
• Valvular or coronary heart disease needing regular follow up
• EF <45% or moderate/severe LV dysfunction
• Active gastrointestinal disease
• Renal failure with creatinine >200 μmol/L or on dialysis
• Active fever or infection
• Life expectancy shorter than the trial
• Allergy to contrast
• Severe cerebrovascular disease
• Bleeding or clotting disorders or inability to receive heparin
• Uncontrolled diabetes (HbA1c ≥73 mmol/mol or HbA1c ≤64 mmol/mol and Fasting Blood Glucose ≥9.2 mmol/L)
• Serum Potassium [K+] <3.5 mmol/L or >5.0 mmol/L
• Malignancy needing surgery, chemotherapy or radiotherapy
• Pregnancy or women of child-bearing potential not using a highly effective method of contraception
• Must not have previous (4 weeks prior to screening) or current participation in another clinical trial with an investigational drug or investigational device
• Unable to give informed consent
• Uncontrolled thyroid disease defined as abnormal thyroid function tests causing cardiac manifestations within the last 6mths
• Unable to attend follow up visits