A Randomized Control Study of Catheter Ablation Versus Surgical Ablation as a Treatment in Patients With 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 evaluating the efficacy and safety of catheter ablation and surgical ablation 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 the group A (circumferential pulmonary vein isolation + linear ablation + bi-atrial mapping + driver ablation), group B (circumferential pulmonary vein isolation + linear ablation + vein of Marshall ethanol infusion) and group C (surgical ablation). Postoperative recurrence rate and other indicators are analyzed to evaluate the efficacy and safety of catheter ablation and surgical ablation 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 + vein of Marshall ethanol infusion
干预措施: Circumferential pulmonary vein isolation + linear ablation + vein of Marshall ethanol infusion (Procedure)
Group C
Surgical ablation
干预措施: Surgical ablation (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 enrollment
AF/AFL/AT recurrence is defined as presence of documented AF/AFL/AT episodes of 30 seconds or longer duration
次要结局
- Postoperative AF recurrence rate(up to 12 months after enrollment)
- Postoperative AFL/AT rate(up to 12 months after enrollment)
- Incidence of complications(up to 12 months after enrollment)
- Changes in the diameter of the left atrium and the left ventricular ejection fraction(up to 12 months after enrollment)
研究者
Xu Liu
Professor, deputy director of cardiology department of Shanghai Chest Hospital
Shanghai Chest Hospital