NCT00863213已完成4 期
Study of Ablation Versus antiaRrhythmic Drugs in Persistent Atrial Fibrillation
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 152
- 试验地点
- 8
- 主要终点
- Freedom from atrial arrhythmias, lasting more than 24 hours or requiring cardioversion.
研究概览
简要总结
The purpose of this study is to compare the effectivity and safety of atrial fibrillation ablation, in comparison to antiarrhythmic drug therapy in patients with refractory, persistent atrial fibrillation.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with persistent atrial fibrillation (more than 7 days, or less than 7 days needing pharmacologic or electric cardioversion)
排除标准
- •Hypo or hyperthyroidism
- •Persistent atrial fibrillation lasting more than 1 year or non-defined duration
- •Hypertrophic myocardiopathy
- •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
- •Contraindication to anticoagulation
- •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
- •Any cause that contraindicate ablation procedure or antiarrhythmic drug
研究组 & 干预措施
Atrial Fibrillation Ablation
Experimental
干预措施: Atrial fibrillation ablation (Procedure)
Drug therapy
Active Comparator
干预措施: Antiarrhythmic drug (Drug)
结局指标
主要结局
Freedom from atrial arrhythmias, lasting more than 24 hours or requiring cardioversion.
时间窗: 1-year follow-up
次要结局
- Freedom from atrial arrhythmias (lasting more than 30 seconds) without antiarrhythmic drugs.(1-year follow-up)
- Decrease in frequency and duration of atrial fibrillation or atrial flutter recurrences.(1-year follow-up)
- Decrease in atrial fibrillation/atrial flutter related hospital admissions(1-year follow-up)
- Improve in quality of life measured with standard questionary for Atrial Fibrillation: AF-QoL.(1-year follow-up)
- Change in need of cardioversions(From 3rd to 12th months)
- Need of atrio-ventricular node ablation(1-year follow-up)
- Need of crossover to the other arm of the study (only when primary end point has been reached)(1-year follow-up)
- Need of a new intervention or ablation during blanking period(Until 3rd month)
- Detection of asymptomatic episodes by Reveal XT(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
MD Phd
Hospital Clinic of Barcelona
研究点 (8)
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