NCT04659213已完成不适用
Esophagus Deviation During Radiofrequency Ablation of Atrial Fibrillation - EASY AF STUDY
S4 Medical2 个研究点 分布在 1 个国家目标入组 129 人开始时间: 2021年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 129
- 试验地点
- 2
- 主要终点
- Incidence of esophageal injury attributable to RF ablation energy as noted on post ablation endoscopy
研究概览
简要总结
To assess if deviating the esophagus will reduce/eliminate ablation injury to the esophagus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The study subjects will not know which treatment arm they were randomized to. Additionally, the gastroenterologist performing the endoscopy post-procedure will also be blinded to the treatment arm.
入排标准
- 年龄范围
- 22 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female age ≥ 22 years and < 80 years
- •Clinical decision to proceed with AF ablation procedure.
- •Ablation procedure to be completed with General Anesthesia
- •Ablation procedure to be completed with use of radiofrequency catheter ablation
排除标准
- •History of various esophageal pathology such as esophageal achalasia, varices, strictures, web, carcinoma, tumor/mass, scleroderma, Mallory-Weiss tear, Barrett's esophagitis, diverticulum, banding, laceration, perforation, balloon dilatation.
- •Presence of a pH probe deployed in the esophagus
- •Planned AF ablation procedure to be completed with laser energy or with cryo-energy
- •Acute or uncontrolled psychiatric illness
- •Unable to undergo upper endoscopy
- •Enrollment in another FDA clinical trial
- •Unstable medical condition(s) that precludes safely completing study protocol
- •Subject is incarcerated
- •Subject is pregnant
- •Subject is unable to comprehend the details of the study
- •The Investigator believes that the subject will be unwilling or unable to comply with study protocol requirements, including the investigational device procedure and study-related follow up visit requirements
结局指标
主要结局
Incidence of esophageal injury attributable to RF ablation energy as noted on post ablation endoscopy
时间窗: 15-72 hours post-ablation procedure
The primary study endpoint is the incidence of esophageal injury attributable to RF ablation energy as noted on post ablation endoscopy
次要结局
未报告次要终点
研究者
研究点 (2)
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