Efficacy of Two-stage Hybrid Ablation or Thoracoscopic Epicardial Ablation for Long-standing Persistent Atrial Fibrillation: A Prospective, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Atrial tachyarrhythmia recurrence
研究概览
简要总结
Hybrid ablation, as an emerging strategy for atrial fibrillation (AF) in recent years, shows encouraging outcomes in many medical centers. A lot of cases demonstrated hybrid ablation has higher success rate than surgical ablation on patients with persistent AF, especially long-standing persistent AF (LSPAF). But it is still lack of high level evidence to prove it.
This study focus on patients with long-standing persistent atrial fibrillation (LSPAF). In order to compare the efficacy and safety of hybrid ablation (two-stage) versus thoracoscopic surgical ablation, a randomized, controlled clinical trial will be performed in the population of LSPAF patients.
详细描述
In this study, all selected LSPAF patients will receive thoracoscopic surgical ablation. After 3 months of blanking-period, patients off antiarrhythmic therapy freedom from atrial arrhythmia (including atrial tachycardia, atrial flutter and atrial fibrillation) will be divided into Hybrid group and Surgical group randomly and equally. Patients of Hybrid group will receive transcatheter endocardial electrophysiological mapping and catheter ablation after randomization subsequently. In followed 2 years, cardiovascular risk control will be recommended to 2 groups' patients.
During the 2-year follow-up, 7d-Holter will be used to monitor patients' rhythm and cardiac conditions will be confirmed by transthoracic echocardiography (TTE). Physical examination and examinations mentioned above will be performed in 3 months, 6 months, 12 months, 18 months, 24 months and suspected recurrence.
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
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Older than 18 years old.
- •Nonvalvular and long-standing persistent atrial fibrillation confirmed by echocardiography and electrocardiography respectively.
- •Written informed consent
排除标准
- •Secondary atrial fibrillation caused by other reversible diseases.
- •Left atrial diameter >55mm confrimed by Transthoracic echocardiography.
- •Intracardial mass or thrombus.
- •Previous cardiac surgery.
- •Uncontrolled heart failure or LVEF less than 30%.
- •Severe chest wall deformity.
- •Possibly pleural adhesion or pericardial adhesion caused by previous thoracic surgery, tuberculosis or constrictive pericarditis.
- •Severe comorbidities (e.g. severe CAD, severe renal failure, severe liver failure).
- •Life expectancy less than 2 years (e.g. patients with MODS or cancer)
- •Unsuitable for radiation exposure (e.g. pregnancy)
研究组 & 干预措施
Two-stage hybrid abltaion
After thoracoscopic surgical ablation and 3 months of blanking-period, patients in this group will receive percutaneous catheter ablation and recommendations about cardiovascular risk control.
干预措施: Hybrid ablation (Procedure)
Thoracosopic surgical ablation
After thoracoscopic surgical ablation and 3 months of blanking-period, patients in this group will only receive recommendations about cardiovascular risk control.
干预措施: Thoracoscopic surgical ablation (Procedure)
结局指标
主要结局
Atrial tachyarrhythmia recurrence
时间窗: 24 months after blanking-period.
Atrial arrhythmia (including atrial tachycardia, atrial flutter and atrial fibrillation) longer than 30s, off antiarrhythmic therapy, recorded by ECG or Holter.
次要结局
- Left atrial thrombus(At 3months, 6months, 12months, 18months, 24months after intervention.)
- Systemic atrial embolism(24 months after blanking-period.)
研究者
Huiming Guo
Director of department of adult cardiac surgery
Guangdong Academy of Medical Sciences