A Randomized Control Trial to Compare the Efficacy and Safety of CARTO-Finder-guided Ablation Plus Pulmonary Vein Isolation and Multiscale Entropy-guided Ablation Plus Pulmonary Vein Isolation in Patients With Persistent Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 1
- 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 randomized control trial to compare the efficacy and safety of CARTO-Finder-guided ablation plus pulmonary vein isolation versus multiscale entropy (MSE)-guided pulmonary vein isolation in patients with persistent atrial fibrillation.
详细描述
This is a randomized control trial. Patients with persistent atrial fibrillation are enrolled and randomized to CARTO-Finder-guided ablation plus PVI group or MSE-guided ablation plus PVI group. Postoperative recurrence rate and other indicators are analyzed to compare the efficacy and safety between CARTO-Finder-guided ablation plus PVI and MSE-guided ablation plus PVI in patients with persistent atrial fibrillation.
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, Outcomes Assessor)
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;
- •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 24 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 24 months after enrollment)
- Postoperative AF recurrence rate(up to 24 months after enrollment)
研究者
Xu Liu
Professor, deputy director of cardiology department of Shanghai Chest Hospital
Shanghai Chest Hospital