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临床试验/NCT00650728
NCT00650728已完成不适用

Esophagus Imaging for Radiofrequency Ablation of Atrial Fibrillation: Comparison of Two Methods

Luzerner Kantonsspital2 个研究点 分布在 1 个国家开始时间: 2008年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
试验地点
2
主要终点
Accuracy of localization of the esophagus in relation to the left atrium

研究概览

简要总结

As the left atrium is in close vicinity to the esophagus, radiofrequency ablation in the left atrium may damage the esophagus and create esophageal perforations and esophageal left atrial fistula. The aim of the present study is to compare different methods for visualization of the esophagus to prevent this complication.

详细描述

Percutaneous catheter ablation with circumferential pulmonary vein isolation using radiofrequency energy has become an important therapeutic option to treat atrial fibrillation over the last years. Importing images from pre-acquired 3-D CT or MRI scans into the 3-D mapping system with superimposition of the electro-anatomical map is increasingly used. Despite these advances, the interventional electrophysiologist must be aware of potential complications that are associated with this procedure. As the left atrium is in close vicinity to the esophagus, radiofrequency ablation in the left atrium may damage the esophagus and create esophageal perforations and esophageal left atrial fistula. To prevent this lethal complication integration of an esophagus tag into the electroanatomic left atrium map visualizing the anatomic relationship has been studied und reported. Another possibility of visualization of the esophagus is to perform the CT after placing a conventional radio-opaque gastric tube, which provides information about the course of the esophagus in relation to the LA and may be scanned by CT . It has been shown that under normal conditions, if no barium is administered, there is little change in the anatomical relationship between the posterior left atrium and the esophagus during the entire cardiac cycle. However it is not clear whether the position of the esophagus in relation to the left atrium is changing over days.

The aim of the present study is to evaluate whether visualization of the esophagus by placing a conventional gastric tube before performing the CT scan and visualization and integration of the esophagus into the 3-D electro-anatomical map the day before ablation is accurate compared with integration of an esophagus tag into the electroanatomic left atrium map visualizing the anatomic relationship during the radiofrequency ablation.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
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

  • Patients with atrial fibrillation undergoing radiofrequency ablation

排除标准

  • 未提供

结局指标

主要结局

Accuracy of localization of the esophagus in relation to the left atrium

时间窗: one year

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (2)

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