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

Not Applicable

Completed

• Conditions: Heart Failure; Recurrent Atrial Fibrillation
• Interventions: Procedure: AVATAR-AF ablation; Procedure: Conventional AF ablation; Drug: Anti-Arrhythmic therapy

• Registration Number: NCT02459574
• Lead Sponsor: Imperial College London

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2015-04-24
• Study Start: 2015-05-01
• Study First Submitted QC: 2015-05-28
• Study First Posted: 2015-06-02
• Primary Completion: 2018-09-30
• Study Completion: 2018-11-27
• Results First Submitted: 2022-08-25
• Status Verified: 2024-10
• Results First Submitted QC: 2024-10-03
• Last Update Submitted: 2024-10-03
• Results First Posted: 2024-10-09
• Last Update Posted: 2024-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 321

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1-AVATAR-AF Ablation Protocol	AVATAR-AF ablation	AF ablation with pulmonary vein isolation. The patient will have two sheaths in their leg veins instead of the usual three sheaths. Catheters will be passed up to the heart from these leg veins. The single crossing into the left atrium will be by the usual method. Veins will be ablated using freeze technology known as the Advance Cryoballoon. After the ablation is completed the patient will have scans on their heart and checks of the leg veins. If all the checks are satisfactory at six hours after the procedure the patient will be allowed to go home on the same day. The patient will be reviewed in clinic in 8 weeks (visit 1) after the procedure and if it has been successful, will be reviewed again a month later (visit 2) and if all is well, the patient will be discharged from clinic.
Group 3-Conventional AF Ablation	Conventional AF ablation	This will involve an ablation procedure carried out in the usual manner. The patient will have three sheaths placed in the leg veins. Catheters will be passed up to the patient's heart from these veins. Two crossing are required into the left atrium. The ablation will involve freeze technology using the Advance Cryoballoon. It will include measuring the electrical signals and may also involve radiofrequency or 'burning' technology in addition.
Group 2-Anti-arrhythmic therapy	Anti-Arrhythmic therapy	Anti-arrhythmic drugs: On the treatment start date the patient will have a new tablet prescribed or a change in the dosage of the medication. The patient will be reviewed at 8wks (visit 1) later to see if the medication is working. If the tablets are working, the patients medication will be left unchanged. If not, an alternative tablet or a higher dose will be used.

Primary Outcome Measures

Name	Time	Method
All Hospital Episodes (Emergency Room or Patient Request for OPD) Related to Treatment for Atrial Arrhythmia	12 months	Composite outcome measure - Hospital episodes (Emergency Room or Patient Request for OPD) Related to Treatment for Atrial Arrhythmia

Secondary Outcome Measures

Name	Time	Method
Death or Stroke From Any Cause	12 months	Composite outcome 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)	12 months	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)
All Hospital Episodes Which Result in a Change in Therapy for Atrial Arrhythmia	12 months	Composite outcome measure - All hospital episodes which result in a change in therapy for atrial arrhythmia

Trial Locations

Locations (13)

The Royal Bournemouth Hospital; 🇬🇧 Bournemouth, United Kingdom

Brighton University Hospital; 🇬🇧 Brighton, United Kingdom

Coventry University Hospital; 🇬🇧 Coventry, United Kingdom

Leeds General Infirmary; 🇬🇧 Leeds, United Kingdom

St Bartholomew's Hospital; 🇬🇧 London, United Kingdom

Liverpool Heart and Chest Hospital; 🇬🇧 Liverpool, United Kingdom

Hammersmith Hospital; 🇬🇧 London, United Kingdom

Freeman Hospital; 🇬🇧 Newcastle, United Kingdom

Queen Alexandra Hospital; 🇬🇧 Portsmouth, United Kingdom

Eastbourne District General Hospital; 🇬🇧 Eastbourne, United Kingdom

Sheffield University Hospital; 🇬🇧 Sheffield, United Kingdom

New Cross Hospital; 🇬🇧 Wolverhampton, United Kingdom

Castle Hill Hospital; 🇬🇧 Hull, United Kingdom