Study of Cryomaze Procedure Using Nitrous Oxide Versus Argon Gas
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- recurrence of atrial fibrillation
研究概览
简要总结
The aim of this study is compare the surgical convenience and early and long-term outcomes of cryomaze procedure using nitrous oxide with using Argon gas.
The investigators will analyze the pathologic findings of atrial tissue after cryoablation using two probes and early and long-term outcomes with Holter monitoring. Atrial fibrillation burden 3 months and 1 year postoperatively and atrial activity will be checked.
详细描述
The investigators have used the Medtronic ATS cryoprobe (Argon based) since 2009 for cryomaze procedure for treatment of atrial fibrillation combined with valvular heart disease.
However, sometimes, it was inconvenient due to excess flexibility, wide lesion related to excess low temperature and time-consuming detachment from atrium after cryoablation. The investigators introduced Atricure cryoprobe (Nitreos Oxide based) in hope of overcoming these shortcomings of ATS probes last year.
Up to date, the investigators have been satisfactory in terms of the surgical convenience. On the other hand, we have the questionability of transmural lesion of Atricure probe because of the higher temperature of Atricure probe compared with ATS probe.
The aim of this study is compare the surgical convenience and early and long-term outcomes of cryomaze procedure using nitrous oxide with using Argon gas.
The investigators will analyze the pathologic findings of atrial tissue after cryoablation using two probes and early and long-term outcomes with Holter monitoring. Atrial fibrillation burden 3 months and 1 year postoperatively and atrial activity will be checked.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •requiring concomitant maze operation with valve surgery (persistent atrial fibrillation)
- •between 18 and 75 years old
排除标准
- •previous cardiac surgery
- •Behcet disease
- •Takayasu's arteritis
- •Infective endocarditis
- •Congenital heart disease
- •left atrial size over 80mm
- •moderate or greater functional tricuspid regurgitation
研究组 & 干预措施
Argon gas probe
Cryomaze procedure using Argon gas probe
干预措施: Cryomaze procedure using Argon (Device)
Nitrous oxide probe
Cryomaze procedure using Nitrous oxide probe
干预措施: Cryomaze procedure using Nitrous oxide (Device)
结局指标
主要结局
recurrence of atrial fibrillation
时间窗: one year
Treatment failure
次要结局
- Postoperative stroke(one year)
- Atrial arrhythmia events(one year)
- Cardiac related death(one year)
- heart failure(one year)
- Reoperation(one year)
- Intracranial hemorrhage(one year)