Surface Electrocardiogram (ECG) Signal Recording for Implantable Subcutaneous String Defibrillator (ISSD) Development
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- NewPace Ltd
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- successful recording of Electrocardiogram (ECG) from a patient containing arrhythmia
研究概览
简要总结
Record cutaneous Electrocardiogram (ECG) data from positions corresponding to the expected subcutaneous locations of the Implantable Subcutaneous String Defibrillator (ISSD) using existing, approved ECG recording devices.
详细描述
2 electrodes places near the sternum and 2 near the midaxillary line, simulating the expected positions of Implantable Subcutaneous String Defibrillator (ISSD) sense electrodes. reference ECG electrodes are also attached (in most cases). Approved ECG recording devices are used to record the signal continuously: During an EP session (different types) a bedside recorder, and a holter monitor is used during holter recordings. Ep session recordings are performed in order to capture different types of arrhythmia, and holter recordings are performed to observe changes in ECG morphology due to activity, position changes, circadian cycles etc. The data is saved and used in the development of the ISSD.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 接受健康志愿者
- 否
入选标准
- •Candidate for ICD implantation
- •Candidate for EP study
- •Candidate for 24 hour holter monitor recording
排除标准
- 未提供
结局指标
主要结局
successful recording of Electrocardiogram (ECG) from a patient containing arrhythmia
时间窗: immediate
recorded Electrocardiogram (ECG) of patients with as many arrhythmia events as possible, preferably tachy-arrhythmia events such as fast VT, flutter or VF
次要结局
未报告次要终点