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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Heart Failure, Recurrent Atrial Fibrillation

Intervention / Treatment
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* Procedure: AVATAR-AF ablation
* Drug: Anti-Arrhythmic therapy
* Procedure: Conventional AF ablation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 3-Conventional AF Ablation<br>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. | Procedure: Conventional AF ablation<br>* Conventional ablation procedure<br>* Other names: Ablation method-surgical;|
| Active Comparator: Group 2-Anti-arrhythmic therapy<br>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. | Drug: Anti-Arrhythmic therapy<br>* 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.<br>* Other names: Propafenone;|
| Experimental: Group 1-AVATAR-AF Ablation Protocol<br>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. | Procedure: AVATAR-AF ablation<br>* Experimental ablation protocol<br>* Other names: Ablation method-surgical;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All hospital episodes (Emergency Room or patient request for OPD) related to treatment for atrial arrhythmia | Composite outcome measure | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death or stroke from any cause | Composite outcome measure | 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 | 12 months | 
| All hospital episodes which result in a change in therapy for atrial arrhythmia | Composite outcome measure | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart Failure