Evaluation of Interference Between Cell Phones and Implantable Cardioverter Defibrillators
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
- 否
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
Haran Burri, MD
Dr
University Hospital, Geneva
