Comparison Between One-stage Hybrid Ablation and Thoracoscopic Surgical Ablation for Intractable Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Survival rate without any recurrence of AF
研究概览
简要总结
Previous evidence indicated that the outcomes of both video-assisted thoracoscopic surgical ablation and percutaneous radiofrequency ablation therapy for persistent atrial fibrillation (AF) were unsatisfied. Recently, hybrid ablation therapy for AF had encouraging outcomes. However, there were no randomized, controlled clinical studies to prove the effectiveness of this new strategy. This study is aimed to compare the outcomes of hybrid ablation with video-assisted thoracoscopic surgical ablation for persistent AF with enlarged left atrium.
详细描述
This study is aimed to compare the outcomes of hybrid ablation with video-assisted thoracoscopic surgical ablation for persistent AF with enlarged left atrium.
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
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with at least one anti-arrhythmic drugs
- •Persistent AF lasting more than 1 year or with a left atrial diameter>50mm
排除标准
- •Previous percutaneous catheter ablation or surgical ablation
- •Presence of significant structural heart disease (dilated cardiomyopathy, hypertrophic cardiomyopathy, valvular heart disease, untreated coronary artery disease)
- •Left atrial diameter>60mm
- •Previous thoracic or lung operation
- •Left atrial thrombosis or left atrial appendage thrombosis
- •Chronic obstructive pulmonary disease (COPD) (Forced expiratory volume in 1 second (FEV1)/Forced vital capacity (FVC)<70%、FEV1<50% anticipated value)
- •Bilateral carotid artery stenosis>80%
- •Refuse to participate in this study
结局指标
主要结局
Survival rate without any recurrence of AF
时间窗: At 12-month after intervention
Without detections of AF (episodes longer than 30 seconds)
次要结局
- Burden of AF(At 12-month after intervention)
- Quality of life score(preoperative and 12-month after intervention)
- Adverse events(12 months follow up)
- Left atrial function(preoperative and postoperative)
- Survival rate without any recurrence of atrial tachyarrhythmia(At 12-month after intervention)
- postoperative complications(30 days after operation)