跳至主要内容
临床试验/NCT00584922
NCT00584922已完成不适用

Early Detection and Treatment of Esophageal Injury After Catheter Ablation for Atrial Fibrillation

University of Oklahoma1 个研究点 分布在 1 个国家目标入组 175 人开始时间: 2006年12月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
175
试验地点
1
主要终点
Incidence of Esophageal Injury as Assessed by Endoscopy

研究概览

简要总结

The purpose of this study is to prospectively follow the next 200 patients who undergo catheter ablation of atrial fibrillation for symptoms and signs of esophageal injury.

详细描述

The purpose of this study is to prospectively follow the next 200 patients who undergo catheter ablation of atrial fibrillation and endoscopy. If any signs of esophageal injury are seen on endoscopy the patients will be treated with omeprazole and sucralfate and they will have repeat endoscopy in two weeks. Patients who do not have any esophageal injury will be contacted by telephone in two weeks to be assessed for GI symptoms.

Specific Aims: The specific aims of the study are to:

  1. Assess the incidence of visible transmural esophageal injury following extensive ablation in the posterior left atrium as measured by endoscopy1
  2. Assess whether early detection of esophageal injury by endoscopy and treatment will prevent development of more serious injury such as left atrial-esophageal fistula
  3. Identify predictors of esophageal injury. In particular, to assess if esophageal temperature rises during ablation correlate with development of esophageal injury and if the absence of esophageal temperature rise during ablation correlate with the absence of esophageal injury.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

入选标准

  • 18-80 years
  • Scheduled to have catheter ablation of atrial fibrillation or left atrial macroreentrant tachycardia.

排除标准

  • Contraindication to endoscopy
  • Pregnancy
  • Prisoners
  • Inability or unwillingness to give informed consent

结局指标

主要结局

Incidence of Esophageal Injury as Assessed by Endoscopy

时间窗: 1 month

Endoscopy results and clinical status at one month after endoscopy procedure.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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