Optimal Ablation Endpoint for Longstanding Persistent Atrial Fibrillation: a Randomized Prospective Study
试验速览
- 阶段
- 不适用
- 入组人数
- 450
- 试验地点
- 1
- 主要终点
- Time to first documented recurrence of atrial arrhythmias
研究概览
简要总结
This randomized prospective study compared three ablation strategies in patients with longstanding persistent atrial fibrillation (LPeAF). It also explored the best procedural endpoint from among the following: circumferential pulmonary vein isolation (PVI)+left atrial (LA) linear lesions (roof line, mitral isthmus)+complex fractionated atrial electrogram (CFAE) ablation, PVI+LA linear lesions +cavotricuspid isthmus (CTI) ablation +CFAE ablation, and PVI+CFAE ablation.
详细描述
Patients were randomized into three ablation groups: group A (n=100): PVI+LA linear ablation (roof line and mitral isthmus) +CFAE ablation; group B (n=100): PVI+linear ablation (roof line, mitral isthmus, and CTI) +CFAE ablation; group C (n=100), PVI+CFAE 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with longstanding persistent atrial fibrillation (lasting for>1 year)
- •Exhibited refractoriness to at least one antiarrhythmic drug
- •Left atrial diameter <=60mm
排除标准
- •Patients with uncontrolled congestive heart failure
- •Having significant valvular disease and/or prosthetic heart valve(s)
- •With myocardial infarction or stroke within 6 months of screening
- •With Significant congenital heart disease;ejection fraction was <40% measured by echocardiography
- •Allergic to contrast media
- •Contraindication to warfarin or heparin
- •Severe pulmonary disease e.g. restrictive pulmonary disease
- •Chronic obstructive disease (COPD)
- •Left atrial (LA) thrombus measured by pre-procedure transesophageal echocardiography
- •Having any contraindication to right or left sided heart catheterization
- •Poor general health
- •Life expectancy less than 6 months
结局指标
主要结局
Time to first documented recurrence of atrial arrhythmias
时间窗: 2-year follow-up
Time to first documented recurrence of atrial arrhythmias after the first ablation procedure and after the final ablation procedure
次要结局
- Number of redo procedures(2-year follow-up)
- Procedure duration at ablation(At the end of the first ablation procedure)
- Ablation time at ablation(At the end of the first ablation procedure ])
- Fluoroscopy time at ablation(At the end of the first ablation procedure)
- Complications(2-year follow-up)
- Type of recurrent arrhythmia(2-year follow-up)
研究者
wang yuanlong
MD
Shanghai Chest Hospital