Credit-AF: A Randomized Control Study of Driver Ablation Combined With Circumferential Pulmonary Vein Isolation Versus Stepwise Ablation as a Treatment in Patients With Persistent Atrial Fibrillation.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,298
- 试验地点
- 1
- 主要终点
- Postoperative atrial fibrillation (AF) recurrence rate
研究概览
简要总结
This is an open label, multi-center, randomized parallel control clinical trial, to demonstrate the role of driver mechanism in maintenance substrate of persistent atrial fibrillation, and evaluate the clinical outcomes of driver mapping and ablation strategy in patients with persistent atrial fibrillation.
详细描述
This is an open label, multi-center, randomized parallel control clinical trial. Patients with persistent atrial fibrillation are 1:1 randomized into the experimental group (driver ablation+ circumferential pulmonary vein isolation) or the control group (stepwise ablation). Postoperative atrial fibrillation recurrence rate and other indicators are analyzed to demonstrate the role of driver mechanism in maintenance substrate of persistent atrial fibrillation and evaluate the clinical outcomes of driver mapping and ablation strategy in patients with 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 to 80 years old;
- •Persistent AF;
- •nonresponse or intolerance to ≥1 antiarrhythmic drug. -
排除标准
- •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 anticoagulation medications;
- •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;
- •Previous atrial fibrillation ablation;
- •Presence of an implanted cardioverter-defibrillator;
- •Any cardiac surgery within the past 2 months;
- •Poor general health;
- •Life expectancy less than 6 months.
结局指标
主要结局
Postoperative atrial fibrillation (AF) recurrence rate
时间窗: up to 24 months after enrollment
AF recurrence is defined as presence of documented AF episodes of 30 seconds or longer duration.
Procedural AF termination rate
时间窗: Before the end of procedure.
AF termination is defined as conversion to sinus rhythm or a stable atrial flutter (AFL)/atrial tachycardia (AT).
次要结局
- Postoperative atrial flutter (AFL) or atrial tachycardia (AT) rate(up to 24 months after enrollment)
- Incidence of complications(up to 2 weeks after enrollment)
研究者
Xu Liu
Professor, deputy director of cardiology department of Shanghai Chest Hospital
Shanghai Chest Hospital