Benefit of Left Atrial Roof Ablation in Paroxysmal Atrial Fibrillation
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Freedom from atrial arrhythmias without antiarrhythmic drugs
研究概览
简要总结
The aim of the present study is to assess whether left atrial roof ablation adds any benefit in the arrhythmia-free probability after paroxysmal atrial fibrillation ablation.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Drug-refractory paroxysmal atrial fibrillation
排除标准
- •Hypo or hyperthyroidism
- •Implantable defibrillation or pacemaker implanted
- •Moderate or severe mitral valve disease or mitral prosthetic valve
- •Ejection fraction less than 30%
- •Left atrial anteroposterior diameter more than 50 mm.
- •Previous atrial fibrillation ablation
- •Left atrium thrombus
- •Current infective disease or sepsis
- •Pregnant women
- •Current unstable angor
- •Acute myocardial infarction in last 3 months
- •Atrial fibrillation secondary to ionic disturbance, thyroids disease or secondary to any other reversible or non cardiovascular disease
- •Reduced expectancy of life (less than 12 months)
- •Patient participating in another clinical study that investigates a drug or device
- •Psychologically unstable patient or denies to give informed consent
研究组 & 干预措施
Conventional ablation
Pulmonary vein encircling by performing continuous radiofrequency lesions surrounding each ipsilateral pulmonary vein antrum
干预措施: Pulmonary vein encircling (Procedure)
Conventional ablation plus left atrial roof ablation
Pulmonary vein encircling by performing continuous radiofrequency lesions surrounding each ipsilateral pulmonary vein antrum plus creation of a radiofrequency line joining contralateral superior pulmonary veins throughout the left atrial roof.
干预措施: Pulmonary vein encircling plus roof ablation (Procedure)
结局指标
主要结局
Freedom from atrial arrhythmias without antiarrhythmic drugs
时间窗: 1-year follow-up
次要结局
- Freedom from atrial arrhythmias with or without antiarrhythmic drugs(1-year follow-up)
- Presence of any complications in the acute phase or during follow-up(1-year follow-up)
研究者
Josep Lluis Mont Girbau
Head of the Arrhythmia Unit
Hospital Clinic of Barcelona