Data Collection for Pacemaker Recognition Through Capacitive ECG
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Sensitivity and Specificity of Paced Rhythm Identification
研究概览
简要总结
This study evaluates the signal quality of capacitive ECG (cECG) on pacemaker patients and whether paced rhythms of the pacemaker can be distinguished from the normal beats using cECG signals.
详细描述
In contrast to classical gold-standard ECG, cECG electrodes can sense the electrical activity of the heart even over the clothing of the subject, which allows several applications in out-of-hospital monitoring. The proposed scenarios for cECG revolve around the unobtrusiveness of the measurement with an inferior signal quality to gold standard ECG. The electrical spikes, that come into existence due to the paced rhythms given by a pacemaker, are only visible in ECG signals recorded by adequate medical instrumentation. Whether cECG can deliver enough signal quality to identify the electrical spikes of the paced rhythms needs to be investigated by recording simultaneous normal and capacitive ECG signals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has an implanted pacemaker
- •Subject is under ambulatory or stationary treatment in Uniklinik RWTH Aachen
- •Subject gives his/her written consent
- •Subject is legally and mentally competent to follow the instructions
排除标准
- •Subject has other electrically active implants
- •Cardiopulmonary or hemodynamically unstable subjects
- •Subject is placed in a judicial institution
- •Subject is in a dependency or employment relationship with the examiner
- •Subject is legally or mentally unable to give consent for the participation
研究组 & 干预措施
Patients having a pacemaker
Patients having a pacemaker will sit down on a seat bearing capacitive ECG electrodes during their routine heart checkup at the cardiology. Simultaneously standard routine ECG measurements will take place.
干预措施: Capacitive ECG (Device)
结局指标
主要结局
Sensitivity and Specificity of Paced Rhythm Identification
时间窗: up to 10 weeks after the data collection is completed for each patient
Cardiologists are asked to classify the heart-beats as "paced" and "normal" in a blind test of mixed normal and capacitive ECG recordings.
次要结局
未报告次要终点
研究者
Nikolaus Marx
Univ.-Prof. Dr. med.
RWTH Aachen University