Evaluation of Interference Between Cell Phones and Implantable Cardioverter Defibrillators
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
GE
-
Geneva、GE、瑞士、1211
- University Hospital Geneva
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Implantation with a wireless-enabled ICD
Exclusion Criteria:
- Age <18yrs
- inability to sign an informed consent
- pacemaker dependancy
学习计划
研究是如何设计的?
设计细节
- 主要用途:诊断
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
无干预:Study group
Evaluation of interference
|
Exposure to cell phone interference of the ICD
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Number of patients who have electromagnetic interference of the ICD when exposed to cell phones.
大体时间:5-10minutes
|
Detection of electromagnetic interference
|
5-10minutes
|
合作者和调查者
调查人员
- 首席研究员:Haran Burri, MD、University Hospital, Geneva
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他研究编号
- 14-245
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
Study group的临床试验
-
Centro Hospitalar do PortoUniversity of Trás-os-Montes and Alto Douro; Foundation for Science and Technology, Portugal; Institute...招聘中