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临床试验/NCT02665442
NCT02665442Unknown不适用

Esophageal Stylet as a Strategy to Minimize the Risk of Esophageal Injury During the Atrial Fibrillation Catheter Ablation Procedure.

Northeast Scientific, Inc.2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2016年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
40
试验地点
2
主要终点
Esophageal injury or erosion

研究概览

简要总结

This Study is designed to determine the outcome and effect of implementation of Esophageal Stylet as a strategy to minimize the risk of esophageal injury during the atrial fibrillation catheter ablation procedure.

详细描述

There is a clear potential to produce transmural esophageal injury during catheter ablation for AF when employing a lesion set targeting the posterior left atrial wall and pulmonary vein (PV) antra using contemporary large-tip or irrigated-tip catheter ablation systems when endocardial target sites are in close proximity to the esophagus.

It is very likely that a movement by the Esophageal Stylet of only 2 to 3 centimeters from the midline can safely protect the esophagus from thermal injury and will mimic the natural migration of the esophagus itself.

The Stylet proposes to safely facilitate lateral esophageal movement in a manner consistent with the esophagus's own natural migration in order to displace and maintain the esophagus's position away from potential damage resulting from a cardiac ablation procedure in the left atrium or coronary sinus.

The Esophageal Stylet is a thin rigid tube, which will be inserted inside a commonly used nasogastric tube placed inside the esophagus during the ablation. We will use this stylet to move the esophagus away from the site of the ablation about 1-2 centimeters. Other common procedures, such as (Trans-esophageal Echocardiogram), move the esophagus twice this distance with a low risk.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

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

  • Age 18 or above for the Patient or legal representative to provide informed consent.
  • Documented paroxysmal or persistent Atrial Fibrillation by a Cardiologist and EKG finding.
  • The patient will undergo Atrial Fibrillation catheter ablation as a treatment plan.

排除标准

  • Bleeding disorder.
  • Dysphagia to solid and liquid or any documented esophageal masses or cancer.
  • Esophageal varices, diverticulum, esophageal web, upper GI bleeding, or hiatal hernia.

结局指标

主要结局

Esophageal injury or erosion

时间窗: 2-3 days post ablation

Decrease of esophageal thermal injury detected by esophageal Pill-Cam

次要结局

  • Total radiofrequency time(Day of ablation procedure)
  • Recurrence of Atrial Fibrillation(12 Months)

研究者

发起方
Northeast Scientific, Inc.
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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