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临床试验/NCT02330900
NCT02330900已完成不适用

Evaluation of Interference Between Cell Phones and Implantable Cardioverter Defibrillators

University Hospital, Geneva2 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2014年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
54
试验地点
2
主要终点
Number of patients who have electromagnetic interference of the ICD when exposed to cell phones.

研究概览

简要总结

Evaluation of electromagnetic interference between modern cell phones and contemporary implantable cardioverter defibrillators (ICDs)

详细描述

Electrograms of ICDs will be analyzed during wireless telemetry and during exposure to an activated cell phone. ICD therapy will have been temporarily inactivated before exposure to cell phones to avoid inappropriate shocks, and the sensitivity level of the ICD will be set to maximum. The cell phones will be held over the ICD generator, as well as in the parasternar region (close to the ICD lead, which senses the signals).

Interference will be assessed by the presence of visible artefacts on the real-time electrogram, with ICD marker annotations showing atrial and/or ventricular sensed episodes. The outcome measure will be the number and proportion of patients who have electromagnetic interference of the ICD when exposed to cell phones.

The procedure will take approximately 5-10minutes, with reprogramming of the device at the end of the test. No further follow-up in the context of the study will be performed.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Implantation with a wireless-enabled ICD

排除标准

  • Age <18yrs
  • inability to sign an informed consent
  • pacemaker dependancy

结局指标

主要结局

Number of patients who have electromagnetic interference of the ICD when exposed to cell phones.

时间窗: 5-10minutes

Detection of electromagnetic interference

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Haran Burri, MD

Dr

University Hospital, Geneva

研究点 (2)

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