Ablation Verses Anti-arrhythmic Therapy for Reducing All Hospital Episodes From Recurrent Atrial Fibrillation (AVATAR-AF)
Heart Failure, Recurrent Atrial Fibrillation
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Heart Failure
Eligibility Criteria
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
Sites / Locations
- The Royal Bournemouth Hospital
- Brighton University Hospital
- Coventry University Hospital
- Eastbourne District General Hospital
- Castle Hill Hospital
- Leeds General Infirmary
- Liverpool Heart and Chest Hospital
- St Bartholomew's Hospital
- Hammersmith Hospital
- Freeman Hospital
- Queen Alexandra Hospital
- Sheffield University Hospital
- New Cross Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
Experimental
Group 3-Conventional AF Ablation
Group 2-Anti-arrhythmic therapy
Group 1-AVATAR-AF Ablation Protocol
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.
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.
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.