A New Theory of Electrophysiological Mechanism of Atrial Fibrillation and Catheter Ablation Therapy for Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Freedom from AF during follow-up
研究概览
简要总结
The electrophysiological mechanisms of atrial fibrillation remain disagreements. The goal of this clinical trail is to propose a new electrophysiological mechanism hypothesis of atrial fibrillation（AF）,meanwhile, the investigators sought to test the hypothesis that the superposition electrograms (SPEs) recorded during atrial fibrillation could be used as target sites for catheter ablation of atrial fibrillation.
详细描述
Catheter ablation for atrial fibrillation is a promising therapy, whose success is limited in part by uncertainty in the electrophysiological mechanisms of AF. The investigators recruited 100 subjects including paroxysmal(40%) and persistent (60%) AF. Cases were prospectively treated, in a 2-arm 1:1 design, by ablation SPEs followed by pulmonary vein isolation(PVI) ablation (n=50), or pulmonary vein isolation alone (n =50).
All procedures are guided by CARTO (Biosense Webster) electroanatomic mapping system and ablation is performed using open irrigated catheters with contact force (CF) sensing (Thermocool SmartTouch, Biosense Webster). Study Group underwent electroanatomic mapping during AF. Using CARTO to identify areas associated with SPEs. Radiofrequency ablation of the area with SPEs was performed, aiming to eliminate SPEs and convert to sinus rhythm or atrial tachycardia.
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 (Participant)
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
- •Patients undergoing a first-time ablation procedure for AF
- •Paroxysmal AF will be defined as a sustained episode lasting > 7 days; Persistent AF will be defined as a sustained episode lasting > 7 days and less than 1 years; Long-lasting persistent AF will be more than 1 year and less than 5 years.
- •Patients must be willing and able to comply with all peri-ablation and follow-up requirements.
- •Patients with atrial fibrillation will to accept the procedure of ablation.
- •Patients signed the written informed consent for the study.
- •Patients can endure the required follow up.
排除标准
- •Patients with contraindications to systemic anticoagulation with heparin or a direct thrombin inhibitor.
- •Patients with thromboembolus in left atrial appendage.
- •Patients with left atrial size ≥ 55 mm (2D echocardiography, parasternal long-axis view).
- •Patients allergic for contrast or iodine.
- •Patients with the serum creatinine（SCr） >3.5mg/dl
- •Patients with life expectancy < 12 months
- •Patients who are in the period of pregnant
结局指标
主要结局
Freedom from AF during follow-up
时间窗: one year
At the one-year follow-up，AF occurring in the first 3 months after the ablation (blanking period) were censored.Beyond this, any AF episode that lasted for more than 30 seconds was categorized as a recurrence.
次要结局
- Acute success rate of AF termination during ablation procedure(one year)
- Complications(one year)
- freedom from documented AF/AT episode(one year)
研究者
mingli Zhou
Principal Investigator
The Second Affiliated Hospital of Kunming Medical University