跳至主要内容
临床试验/NCT01546168
NCT01546168终止不适用

Esophageal Deviation in Atrial Fibrillation Ablation: A Randomized Control Trial

Vivek Reddy4 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2011年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
发起方
入组人数
88
试验地点
4
主要终点
Number of Participants With Presence of Esophageal Injury

研究概览

简要总结

In this randomized double-blind study, the investigators would like to compare standard practice (i.e., use of luminal esophageal temperature monitoring) to that of esophageal deviation during AF ablation. The investigators hypothesize that the strategy of esophageal deviation will result in safer ablation strategy with a reduction in the incidence of esophageal injury as assessed by endoscopy.

详细描述

Catheter ablation is a commonly performed strategy employed for the treatment of atrial fibrillation. However ablation in the posterior wall of the left atrium can cause thermal injury to the esophagus. When significant thermal injury to the esophagus occurs, two significant complications can occur: 1) the formation of an atrio-esophageal fistula, and 2) gastrointestinal dysmotility. While the former is rate, it is an important complication since it can be fatal. The frequency of the latter complication is less well appreciated, but probably occurs in the range of 1:100 to 1:500. Currently luminal esophageal temperature monitoring is the most commonly employed modality to prevent such injury. However, there are limitations to its use, and atrio-esophageal fistulas have been reported even when using esophageal temperature monitoring. Esophageal deviation using either a TEE or EGD probe has been described in the literature, but the effectiveness and practicality of these techniques are suboptimal, and have therefore precluded their use in routine clinical practice. Recently, we have demonstrated that esophageal deviation is indeed possible using off-the-shelf equipment (a soft thoracic tube and endotracheal stylet) in patients undergoing AF ablation. In this randomized double-blind study, we will compare standard practice (i.e., use of luminal esophageal temperature monitoring) to esophageal deviation during AF ablation. We hypothesize that the strategy of esophageal deviation will result in safer ablation strategy with a reduction in the incidence of esophageal injury as assessed by endoscopy.

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
Double (Participant, Outcomes Assessor)

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

  • •Age >18 - Age < 80 yr
  • •Documentation of atrial fibrillation (AF)
  • •Referred for a first ever ablation procedure for AF (prior ablation of right-sided Typical flutter, or "limited" left-sided of an accessory pathway are permitted)
  • •General anesthesia
  • •All patients must understand and adhere to the requirements of the study and be willing to comply with the post study follow-up requirements.

排除标准

  • •Any reversible cause of AF (post-surgery, thyroid disorder, etc.)
  • •INR > 4.0 at the time of the procedure
  • •H/o of severe esophageal ulcers, strictures, esophagitis or GERD
  • •H/o Esophageal Surgery
  • •Prior surgical or catheter ablation procedure for AF (except right atrial flutter ablation)
  • •Any evidence of esophageal diverticulum or other structural abnormalities of the esophagus seen during baseline barium esophagogram
  • •Significant abnormality on Swallowing Impairment Score
  • •Mental impairment precluding signing consent or completing follow up
  • •Patients with any other significant uncontrolled or unstable medical condition
  • •Women who are known to be pregnant or have had a positive β-HCG test 7 days prior to procedure

研究组 & 干预措施

esophageal deviation

Experimental

esophageal deviation with IDE device during AF ablation

干预措施: esophageal deviation with IDE device (Device)

temperature monitoring

No Intervention

luminal esophageal temperature monitoring, standard temperature monitoring alone

结局指标

主要结局

Number of Participants With Presence of Esophageal Injury

时间窗: within 1 week of AF ablation procedure

The presence of esophageal injury as assessed by upper gastrointestinal endoscopy that is performed within 1 week of the procedure.

次要结局

  • Procedure Time(day 1, duration ofAF ablation procedure)
  • Temperature(during AF ablation procedure (intraoperative))
  • Swallowing Impairment Score(during AF ablation procedure (intraoperative))

研究者

发起方
Vivek Reddy
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Vivek Reddy

Director Cardiac Arrhythmia Service, Professor of Medicine

Icahn School of Medicine at Mount Sinai

研究点 (4)

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