NCT05709756已完成不适用
Prevalence and Predictors of Esophageal Thermal Lesions in High-Power-Short-Duration Ablation of Atrial Fibrillation
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:
- The size of the esophageal thermal lesions.
- 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
- 否
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
研究点 (2)
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