Clinical trial NCT02459574: Ablation Verses Anti-arrhythmic Therapy for Reducing All Hospital Episodes From Recurrent Atrial Fibrillation
Official title: Ablation Verses Anti-arrhythmic Therapy for Reducing All Hospital Episodes From Recurrent Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Recurrent Atrial Fibrillation
Keywords: Heart Failure
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2015-06-02
Enrollment: 321
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: All Hospital Episodes (Emergency Room or Patient Request for OPD) Related to Treatment for Atrial Arrhythmia
timeFrame: 12 months
Secondary outcomes:
measure: Death or Stroke From Any Cause
timeFrame: 12 months
measure: 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)
timeFrame: 12 months
measure: All Hospital Episodes Which Result in a Change in Therapy for Atrial Arrhythmia
timeFrame: 12 months
Other outcomes:
Locations:
city: Bournemouth
country: United Kingdom
facility: The Royal Bournemouth Hospital
city: Brighton
country: United Kingdom
facility: Brighton University Hospital
city: Coventry
country: United Kingdom
facility: Coventry University Hospital
city: Eastbourne
country: United Kingdom
facility: Eastbourne District General Hospital
city: Hull
country: United Kingdom
facility: Castle Hill Hospital
city: Leeds
country: United Kingdom
facility: Leeds General Infirmary
city: Liverpool
country: United Kingdom
facility: Liverpool Heart and Chest Hospital
city: London
country: United Kingdom
facility: St Bartholomew's Hospital
city: London
country: United Kingdom
facility: Hammersmith Hospital
city: Newcastle
country: United Kingdom
facility: Freeman Hospital
city: Portsmouth
country: United Kingdom
facility: Queen Alexandra Hospital
city: Sheffield
country: United Kingdom
facility: Sheffield University Hospital
city: Wolverhampton
country: United Kingdom
facility: New Cross Hospital
Study officials:
affiliation: Imperial College London
name: Dr. Prapa Kanagaratnam
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kanagaratnam P, McCready J, Tayebjee M, Shepherd E, Sasikaran T, Todd D, Johnson N, Kyriacou A, Hayat S, Hobson NA, Mann I, Balasubramaniam R, Whinnett Z, Earley M, Petkar S, Veasey R, Kirubakaran S, Coyle C, Kim MY, Lim PB, O'Neill J, Davies DW, Peters NS, Babalis D, Linton N, Falaschetti E, Tanner M, Shah J, Poulter N. Ablation versus anti-arrhythmic therapy for reducing all hospital episodes from recurrent atrial fibrillation: a prospective, randomized, multi-centre, open label trial. Europace. 2023 Mar 30;25(3):863-872. doi: 10.1093/europace/euac253.
citation: Mann I, Sasikaran T, Sandler B, Babalis D, Johnson N, Falaschetti E, Copley A, Tayebjee M, Todd D, Shepherd E, McCready J, Poulter N F, Kanagaratnam P. Ablation versus Anti-Arrhythmic Therapy for Reducing All Hospital Episodes from Recurrent Atrial Fibrillation (AVATAR-AF): Design and rationale. Am Heart J. 2019 Aug;214:36-45. doi: 10.1016/j.ahj.2019.04.015. Epub 2019 May 3.