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临床试验/NCT02392338
NCT02392338已完成不适用

Comparison of Success Rate of Totally Thoracoscopic Ablation Versus Hybrid Procedure in Patients With Persistent Atrial Fibrillation

Samsung Medical Center2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2014年11月最近更新:
适应症

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
Cardiac related death

研究概览

简要总结

In this study, the investigators therefore comparatively analyzed the mid-term results (at 1 year) including electrocardiogram, 24 hour Holter monitoring, and 2 week long-term electrocardiogram of thoracoscopic ablation and RFCA performed individually or as a hybrid procedure in patients with long-lasting persistent atrial fibrillation. Antiarrhythmic medication, discontinuation of anticoagulation medication, and echocardiographic findings were also analyzed.

详细描述

Atrial fibrillation is highly associated with sudden death and stroke, requiring definitive treatment. In Korea, atrial fibrillation is a common disease predicted to affect more than 5% of the population over 65 years of age and more than 10% over 80 years.

Totally thoracoscopic ablation has been adopted and performed successfully on February 2012 at Samsung Medical Center for the first time in Korea. More than 120 operations have been performed up to date.

In Korea, treatment for atrial fibrillation is still dependent on percutaneous RFCA, and life-long medication and anticoagulation is needed when recurrent atrial fibrillation occurs. The investigators expected thoracoscopic ablation to be an alternative to overcome this limitation. Also, thoracoscopic ablation and RFCA are recently being performed simultaneously or stage by stage as a hybrid procedure, and the results are being reported.

In this study, the investigators therefore comparatively analyzed the mid-term results (at 1 year) including electrocardiogram and 24 hour Holter monitoring of thoracoscopic ablation and RFCA performed individually or as a hybrid procedure in patients with long-lasting persistent atrial fibrillation. Antiarrhythmic medication, discontinuation of anticoagulation medication, and echocardiographic findings were also analyzed.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Long-lasting persistent atrial fibrillation
  • Persistent atrial fibrillation refractory to antiarrhythmic drug therapy
  • over 18 years

排除标准

  • Valvular heart disease of more than moderate degree
  • Unresponsive ischemic cardiomyopathy
  • Follow-up of over 1 year was not possible
  • Warfarin was unable to be used
  • Refusal of informed consent
  • Left atrial thrombus

结局指标

主要结局

Cardiac related death

时间窗: one year

medical records review

次要结局

  • Bleeding(postoperative one year)
  • Embolism(postoperative one year)
  • Stroke(postoperative one year)
  • Recurred atrial arrhythmia(postoperative one year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Young Keun On

Professor

Samsung Medical Center

研究点 (2)

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