Ablation Verses Anti-arrhythmic Therapy for Reducing All Hospital Episodes From Recurrent Atrial Fibrillation

Ablation Verses Anti-arrhythmic Therapy for Reducing All Hospital Episodes From Recurrent Atrial Fibrillation

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.

Inclusion Criteria:

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

Exclusion Criteria:

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