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临床试验/NCT05709756
NCT05709756已完成不适用

Prevalence and Predictors of Esophageal Thermal Lesions in High-Power-Short-Duration Ablation of Atrial Fibrillation

Helios Health Institute GmbH2 个研究点 分布在 1 个国家目标入组 263 人开始时间: 2021年3月1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
263
试验地点
2
主要终点
Prevalence of ablation-related esophageal thermal lesions

研究概览

简要总结

Patients with documented atrial fibrillation who were referred to our clinic for catheter ablation will undergo standard HPSD ablation and subsequent esophagoscopy.

After esophagoscopy patients will be followed up for one month in the form of a telephone follow-up.

The primary endpoint of the study assessed by esophagoscopy performed on the day after the index catheter ablaton is the incidence of esophageal thermal lesions.

Secondary endpoints include:

  1. The size of the esophageal thermal lesions.
  2. The severity of esophageal thermal lesions.

研究设计

研究类型
Observational
观察模型
Case Only
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

  • Atrial fibrillation documented in the 12-lead ECG
  • Indication for catheter ablation in accordance with currentn ESC guidelines

排除标准

  • Pregnancy
  • Women of childbearing potential without a negative pregnancy test within 48 hours prior to ablation procedure
  • Known intracardiac or other thrombi
  • Contraindication to anticoagulation
  • Contraindication to esophagoscopy: diseases and deformities of the cervical spine, esophageal varices

结局指标

主要结局

Prevalence of ablation-related esophageal thermal lesions

时间窗: One day after Catheter ablation

It will be assessed by means of Esophagoscopy

次要结局

  • Size of ablation-related esophageal thermal lesions(One day after Catheter ablation)
  • Severity of ablation-related esophageal thermal lesions(One day after Catheter ablation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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