A Randomized Control Study of Driver Ablation of Persistent Atrial Fibrillation With Severe Atrial Fibrosis: a Chinese Registry Study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 300
- 主要终点
- Postoperative atrial fibrillation (AF)/atrial flutter (AFL)/atrial tachycardia (AT) recurrence rate
研究概览
简要总结
This is an open label, randomized parallel control clinical trial, to demonstrate the role of driver mechanism in maintenance substrate of persistent atrial fibrillation with severe atrial fibrosis, and evaluate the clinical outcomes of driver mapping and ablation strategy in patients with persistent atrial fibrillation with severe atrial fibrosis.
详细描述
This is an open label, randomized parallel control clinical trial. Patients with persistent atrial fibrillation with severe atrial fibrosis are 1:1:1 randomized into group A (circumferential pulmonary vein isolation + linear ablation + bi-atrial mapping + driver ablation), group B (circumferential pulmonary vein isolation + linear ablation + posterior wall box isolation) and group C (circumferential pulmonary vein isolation + linear ablation + vein of Marshall ethanol infusion). Postoperative recurrence rate and other indicators are analyzed to demonstrate the role of driver mechanism in maintenance substrate of persistent atrial fibrillation with severe atrial fibrosis and evaluate the clinical outcomes of driver mapping and ablation strategy in patients with persistent atrial fibrillation with severe atrial fibrosis.
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 with severe atrial fibrosis;
- •Nonresponse or intolerance to ≥1 antiarrhythmic drug.
排除标准
- •With uncontrolled congestive heart failure;
- •Having significant valvular disease;
- •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;
- •Having any contraindication to right or left sided heart catheterization;
- •Previous atrial fibrillation ablation;
- •Presence of an implanted cardioverter-defibrillator;
- •Previous history of cardiac surgery;
- •Poor general health;
- •Life expectancy less than 6 months.
研究组 & 干预措施
Group A
Circumferential pulmonary vein isolation + linear ablation + bi-atrial mapping + driver ablation
干预措施: Circumferential pulmonary vein isolation + linear ablation + bi-atrial mapping + driver ablation (Procedure)
Group B
Circumferential pulmonary vein isolation + linear ablation + posterior wall box isolation
干预措施: Circumferential pulmonary vein isolation + linear ablation + posterior wall box isolation (Procedure)
Group C
Circumferential pulmonary vein isolation + linear ablation + vein of Marshall ethanol infusion
干预措施: Circumferential pulmonary vein isolation + linear ablation + vein of Marshall ethanol infusion (Procedure)
结局指标
主要结局
Postoperative atrial fibrillation (AF)/atrial flutter (AFL)/atrial tachycardia (AT) recurrence rate
时间窗: up to 12 months after ablation
AF/AFL/AT recurrence is defined as presence of documented AF/AFL/AT episodes of 30 seconds or longer duration
Intraoperative AF termination rate
时间窗: through ablation completion, an average of 3 hours
AF termination is defined as conversion to sinus rhythm or stable AFL/AT.
次要结局
- Incidence of complications(up to 12 months after ablation)
- Changes in the left ventricular ejection fraction(up to 12 months after ablation)
- Changes in the diameter of the left atrium(up to 12 months after ablation)
- Postoperative AF recurrence rate(up to 12 months after ablation)
- Postoperative AFL/AT rate(up to 12 months after ablation)
研究者
Xu Liu
Professor, deputy director of cardiology department of Shanghai Chest Hospita
Shanghai Chest Hospital