NCT03998956Unknown不适用
Study of High-density Mapping-guided bOx Isolation and subsTrate Ablation for Persistent Atrial Fibrillation
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 主要终点
- sinus rhythm maintenance rate
研究概览
简要总结
This study evaluates the efficacy of high-density mapping guided atrial substrate ablation for persistent atrial fibrillation. 1/5 of the patients with persistent atrial fibrillation undergo pulmonary veins isolation, 2/5 of them pulmonary veins and box isolation while others undergo atrial substrate ablation apart from pulmonary veins and box isolation.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent signed.
- •Age of 18 to 75 years old.
- •Persistent or longstanding persistent atrial fibrillation (≥7 days), which is confirmed by Holter in recent six months.
- •Willing to have catheter ablation for atrial fibrillation.
排除标准
- •Accompanied by serious heart diseases including cardiac valvular diseases, congenital heart diseases, hypertrophic obstructive cardiomyopathy, acute myocardium infarction, unstable anginal pectoris and so on.
- •Complete atrioventricular block.
- •An acute stroke or contradiction of anti-coagulation.
- •Hyperthyroidism.
- •Having a history of catheter ablation of atrial fibrillation.
- •Left atrial appendage thrombosis confirmed by transesophageal echocardiography.
- •Pregnancy or lactation.
- •Planning for pregnancy in the near future.
- •Myopathy or active liver disease, including patients with sustained increase of serum transaminase of unknown reason and the ones with increased serum transaminase over three times the upper limit of normal.
- •Patients of severe renal insufficiency with creatinine clearance lower than 30 ml/min.
研究组 & 干预措施
Circumferential PV isolation
Active Comparator
Circumferential PV isolation only
干预措施: CPVI (Procedure)
Circumferential PV and BOX isolation
Experimental
Circumferential PV and BOX isolation
干预措施: CPVI+BOX (Procedure)
circumferential PV and BOX isolation with substrate ablation
Experimental
Atrial substrate ablation apart from circumferential PV and BOX isolation
干预措施: CPVI+BOX+SUB (Procedure)
结局指标
主要结局
sinus rhythm maintenance rate
时间窗: 12 months
Holter is performed 12months after the procedure and heart rhythm is recorded.
次要结局
- left ventricular ejection fraction(12 months)
- Stroke or embolic events(12 months)
- Atrial fibrosis(1 day)
研究者
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