CatHeter Ablation of perSistEnd Atrial Fibrillation: Pulmonary Vein Isolation Versus Defragmentation. The CHASE-AF Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Recurrence of atrial arrhythmia during 12 months follow up
研究概览
简要总结
Study design:
Randomized prospective comparison of pulmonary vein isolation alone versus a strategy aiming for atrial fibrillation termination by using a stepwise approach consisting of pulmonary vein isolation, biatrial defragmentation aiming for fractionated electrograms and linear ablation if required.
详细描述
Study protocol:
In patients randomized to PVI alone, the index procedure consists of wide circumferential pulmonary vein isolation (1 cm distal of the PV ostium) including optional right atrial isthmus ablation. Endpoint for PVI is entrance block as evaluated by a circumferential mapping catheter during sinus rhythm at the end of the procedure. In all patients the NavX® three-dimensional mapping system should be used. The St. Jude Medical Coolflex® or Coolpath® catheters may be used at the operator's discretion.
In patients randomized to the strategy aiming for atrial fibrillation termination PVI is also the initial step of the procedure followed by atrial defragmentation and eventual linear ablation in case of atrial tachycardia aiming for acute restoration of sinus rhythm. The procedural steps with regard to mapping and ablation of atrial fibrillation and consecutive atrial tachycardia follow the previously described methods (8,9). After initial ablation the previous antiarrhythmic drug treatment can be continued but no de novo antiarrhythmic drug regiment should be applied. The primary endpoint of this study is recurrence of atrial arrhythmias between 6 and 12 months after the initial ablation procedure.
In both study arms, the same CE certified catheters will be used. Usually, the setting consists of on decapolar catheter positioned in the coronary sinus, one circumferential mapping catheters for mapping of the pulmonary veins, one quadripolar catheter for mapping the right atrium. In both study groups a externally irrigated catheter for mapping and ablation will be used (CoolFlex/ Coolpath as mentioned above).
Sample size calculation:
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
- •Age > 18
- •Persistent atrial fibrillation > 7 days or previous cardioversion
- •Obtained written consent
排除标准
- •Age less than 18 years
- •Previous operative or interventional treatment of atrial fibrillation
- •Paroxysmal atrial fibrillation
- •Pregnancy
- •Contraindication for oral anticoagulation
- •Contraindication for heparin administration
- •Transient factors causing atrial fibrillation (e.g. Hyperthyroidism)
- •Drug and alcohol abuse
- •Severe underlying heart disease with left atrial enlargement > 60 mm
研究组 & 干预措施
PVI alone
Pulmonary vein isolation alone in persistent atrial fibrillation
干预措施: PVI alone (Procedure)
PVI + Defragmentation + linear lesions
AF ablation continuation aiming for AF termination
干预措施: PVI + Defragmentation + linear lesions (Procedure)
结局指标
主要结局
Recurrence of atrial arrhythmia during 12 months follow up
时间窗: 12 months
次要结局
- Number of periprocedural complications(12 months)