Evaluating the Electro Magnetic Interference of Using Tablet and Smart Phone on Leadless Pacemaker (MICRA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Number of Participants Experiencing Inhibition of Ventricular Pacing While Using a Smart Phone
研究概览
简要总结
The purpose of this study is to evaluate the effects that electromagnetic field exposure from using a tablet and smart phone have on a leadless pacemaker (MICRA device).
详细描述
With advancement in technology, people are exposed to new sources of electromagnetic field like tablets and smart phones. There are magnets in smart phones and tablets that could affect the functions of pacemakers. The main purpose of this study is to evaluate the effects of electromagnetic field exposure from using a tablet and a smart phone with participants that have a leadless pacemaker (MICRA device) implanted inside them. Participants will be asked to report any symptoms that they experience during the testing.
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
- 是
入选标准
- •Patients enrolled in MICRA Study and MICRA CA study at Emory University Hospital and Emory Midtown Hospital
- •Able to consent
排除标准
- •Patients not enrolled in MICRA Study and MICRA CA study at Emory University Hospital and Emory Midtown Hospital
- •Children and vulnerable populations
研究组 & 干预措施
Participants with MICRA Device
Participants that received the MICRA device prior to study enrollment will have monitored use of Smart Phone and Tablet at one study visit. Electrogram printing will take place during use of each device to see if there is any pacing inhibition or asynchronous pacing.
干预措施: Use of a Tablet (Device)
Participants with MICRA Device
Participants that received the MICRA device prior to study enrollment will have monitored use of Smart Phone and Tablet at one study visit. Electrogram printing will take place during use of each device to see if there is any pacing inhibition or asynchronous pacing.
干预措施: Use of a Smart Phone (Device)
结局指标
主要结局
Number of Participants Experiencing Inhibition of Ventricular Pacing While Using a Smart Phone
时间窗: Baseline (Before use of Smart Phone), During use of Smart Phone (an average of 5 minutes)
Ventricular pacing before and during use of a smart phone was monitored to assess the presence of inhibition of ventricular pacing due to electromagnetic field exposure. The programmed pacing of the MICRA device is specific for each participant. The individualized, initial programmed pacing settings of the MICRA device are compared to any changes during the smart phone usage.
Number of Participants Experiencing Asynchronous Pacing While Using a Tablet
时间窗: Baseline (Before use of Tablet), During use of Tablet (an average of 5 minutes)
Cardiac pacing before and during use of a tablet were monitored to assess if there is asynchronous pacing due to electromagnetic field exposure. The initial programmed pacing settings of the MICRA device are compared to any changes during the tablet usage.
Device Response While Using a Tablet, Assessed by Ventricular Pacing
时间窗: Baseline (Before use of Tablet), During use of Tablet (an average of 5 minutes)
Ventricular pacing before and during use of a tablet was monitored to assess if there's inhibition of ventricular pacing due to electromagnetic field exposure. The initial programmed pacing settings of the MICRA device are compared to any changes during the tablet usage. The assessment of this outcome measure takes an average of 5 minutes.
Device Response Assessed by Asynchronous Pacing When Using a Smart Phone
时间窗: Baseline (Before use of Smart Phone), During use of Smart Phone (an average of 5 minutes)
Cardiac pacing before and during use of a smart phone was monitored to assess asynchronous pacing due to electromagnetic field exposure. The initial programmed pacing settings of the MICRA device are compared to any changes during the smart phone usage.
次要结局
- Number of Participants Reporting Clinical Symptoms While Using a Tablet(Baseline (Before use of Tablet), During use of Tablet (an average of 5 minutes))
- Number of Participants Reporting Clinical Symptoms While Using a Smart Phone(Baseline (Before use of Smart Phone), During use of Smart Phone (an average of 5 minutes))
研究者
Mikhael El Chami
Associate Professor
Emory University