Benefit of Complex Fractionated Atrial Electrograms Elimination in Atrial Fibrillation Ablation
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 142
- 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 this study is to evaluate whether performing complex fractionated atrial electrograms ablation improves outcomes in persistent or 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
- Single (Outcomes Assessor)
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 (more than 7 days, or less than 7 days needing pharmacologic or electric cardioversion)
- •Presence of atrial fibrillation at the beginning of the procedure
排除标准
- •Hypo or hyperthyroidism
- •Persistent long-lasting or non-defined duration atrial fibrillation
- •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
ACVP plus roof line
Standard procedure for atrial fibrillation ablation, including pulmonary vein isolation plus roof line ablation. All ablation lines will be tested.
干预措施: Standard atrial fibrillation ablation procedure (Procedure)
Additional CFAEs ablation
Atrial fibrillation ablation with pulmonary vein ablation and roof line. In addition, complex fractionated atrial electrograms ablation will be performed, lasting at most 30 minutes.
干预措施: Additional Complex Fractionated Electrograms 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 atypical atria flutter(1-year follow-up)
- Freedom form 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)
- Increase in radioscopy time and radiofrequency application time(1-year follow-up)
研究者
Josep Lluis Mont Girbau
Head of the Arrhythmia Unit
Hospital Clinic of Barcelona