NCT04958928Unknown不适用
A Prospective, Multicenter, Cohort Study of Termination of Persistent Atrial Fibrillation by Catheter Ablation
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 400
- 主要终点
- AF recurrence rate
研究概览
简要总结
This is a prospective, multicenter, cohort study aims to demonstrate the role of termination of AF in ablation for persistent atrial fibrillation, and evaluate the clinical outcomes in patients with or without AF termination.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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; 15.Life expectancy less than 6 months.
结局指标
主要结局
AF recurrence rate
时间窗: 12 months
AF recurrence is defined as presence of documented AF episodes of 30 recurrence is defined as presence of documented AF episodes of 30 seconds or longer duration.
次要结局
未报告次要终点
研究者
Xu Liu
Professor
Shanghai Chest Hospital
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