Safety of Screening Procedures With Hand-held Metal Detectors Among Patients With Implanted Cardiac Rhythm Devices
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 388
- 试验地点
- 3
- 主要终点
- Electromagnetic Interference
研究概览
简要总结
Patients with implanted pacemaker (PM) or cardioverter-defibrillator (ICD) systems are restrained in daily life by possible electromagnetic interference (EMI). Case reports suggest EMI between PM or ICD systems and hand-held metal detectors that are intensively used as part of security screening processes in e.g. airport controls.
The objective was to determine the safety of screening procedures for ferrous materials with regard to possible in vivo EMI between hand-held metal detectors and PM and ICD systems.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Patients presenting for routine pacemaker or cardioverter defibrillator control
- •appropriate PM/ICD function
排除标准
- •atrial or ventricular sensing abnormalities that could not be avoided by reprogramming of device parameters
- •low battery status of the device such as elective replacement indicator (ERI)
- •intrinsic heart rate > 120 beats per minute (bpm)
结局指标
主要结局
Electromagnetic Interference
时间窗: time during exposure to hand-held metal detector (2x 30 sec)
inhibition of the pacemaker, loss of capture, inappropriate mode switch, ventricular oversensing, power-on-reset, device reprogramming or loss of function
次要结局
未报告次要终点