Ablation Verses Anti-arrhythmic Therapy for Reducing All Hospital Episodes From Recurrent Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 321
- 试验地点
- 13
- 主要终点
- All Hospital Episodes (Emergency Room or Patient Request for OPD) Related to Treatment for Atrial Arrhythmia
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Group 3-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.
干预措施: Conventional AF ablation (Procedure)
Group 2-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.
干预措施: Anti-Arrhythmic therapy (Drug)
Group 1-AVATAR-AF Ablation Protocol
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.
干预措施: AVATAR-AF ablation (Procedure)
结局指标
主要结局
All Hospital Episodes (Emergency Room or Patient Request for OPD) Related to Treatment for Atrial Arrhythmia
时间窗: 12 months
Composite outcome measure - Hospital episodes (Emergency Room or Patient Request for OPD) Related to Treatment for Atrial Arrhythmia
次要结局
- Death or Stroke From Any Cause(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)(12 months)
- All Hospital Episodes Which Result in a Change in Therapy for Atrial Arrhythmia(12 months)