A Single-arm Study to Evaluate the Efficacy and Safety of Left Atrial Isolation Achieved by Catheter Ablation in Patients With Persistent Atrial Fibrillation and 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
- 50
- 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 a single-arm clinical trial evaluating the efficacy and safety of left atrial isolation achieved by catheter ablation in patients with persistent atrial fibrillation with severe atrial fibrosis.
详细描述
This is a single-arm clinical trial. Patients with persistent atrial fibrillation with severe atrial fibrosis are enrolled as subjects to conduct left atrial isolation by catheter ablation. Postoperative recurrence rate and other indicators are analyzed to evaluate the efficacy and safety of left atrial isolation achieved by catheter ablation in patients with persistent atrial fibrillation with severe atrial fibrosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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 and left atrial anterioposterior diameter > 50mm
- •Nonresponse or intolerance to ≥1 antiarrhythmic drug
- •CHA2DS2-VASc ≥ 3 and HAS-BLED < 3
排除标准
- •With uncontrolled congestive heart failure;
- •Having significant valvular disease;
- •Having moderate-to-severe pulmonary hypertension;
- •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 thrombus;
- •Having any contraindication to right or left sided heart catheterization
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 18 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 AFL/AT rate(up to 18 months after enrollment)
- Postoperative AF recurrence rate(up to 18 months after enrollment)
- Incidence of complications(up to 18 months after enrollment)
- Changes in the diameter of the left atrium and the left ventricular ejection fraction(up to 18 months after enrollment)
研究者
Xu Liu
Professor, deputy director of cardiology department of Shanghai Chest Hospital
Shanghai Chest Hospital