Hybrid Procedure in Patients With Persistent Atrial Fibrillation
Comparison of Success Rate of Totally Thoracoscopic Ablation Versus Hybrid Procedure in Patients With Persistent Atrial Fibrillation
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
-
Seoul、大韩民国、135-710
- Samsung Medical Center
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Long-lasting persistent atrial fibrillation
- Persistent atrial fibrillation refractory to antiarrhythmic drug therapy
- over 18 years
Exclusion Criteria:
- 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
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
无干预:Thoracoscopic ablation group
Patients who will undergo thoracoscopic ablation only
|
|
|
有源比较器:Hybrid procedure
Patients who will undergo hybrid procedure (thoracoscopic ablation and eletrophyologic study with or without additional ablation)
|
Eletrophysiologic study via femoral vein approach to confirm pulmonary vein isolation lesion and box lesions in left atrium
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Cardiac related death
大体时间:one year
|
medical records review
|
one year
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Stroke
大体时间:postoperative one year
|
medical records review at 3, 6 and 12 months follow up
|
postoperative one year
|
|
Bleeding
大体时间:postoperative one year
|
medical records review at 3, 6 and 12 months follow up
|
postoperative one year
|
|
Embolism
大体时间:postoperative one year
|
medical records review at 3, 6 and 12 months follow up
|
postoperative one year
|
|
Recurred atrial arrhythmia
大体时间:postoperative one year
|
medical records review at 3, 6 and 12 months follow up
|
postoperative one year
|
合作者和调查者
调查人员
- 首席研究员:Young Keun On, MD,PhD、Samsung Medical Center
出版物和有用的链接
一般刊物
- Pison L, La Meir M, van Opstal J, Blaauw Y, Maessen J, Crijns HJ. Hybrid thoracoscopic surgical and transvenous catheter ablation of atrial fibrillation. J Am Coll Cardiol. 2012 Jul 3;60(1):54-61. doi: 10.1016/j.jacc.2011.12.055.
- Choi MS, On YK, Jeong DS, Park KM, Park SJ, Kim JS, Carriere KC. Usefulness of Postprocedural Electrophysiological Confirmation Upon Totally Thoracoscopic Ablation in Persistent Atrial Fibrillation. Am J Cardiol. 2020 Apr 1;125(7):1054-1062. doi: 10.1016/j.amjcard.2019.12.046. Epub 2020 Jan 8.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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