Surface ECG Signal Recording for the Implantable Subcutaneous String Defibrillator (ISSD) Detection Algorithm Performance Assessment
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Tachyarrhythmia
- 发起方
- NewPace Ltd
- 入组人数
- 91
- 试验地点
- 1
- 主要终点
- ISSD algorithm detection rates
- 状态
- 已完成
- 最后更新
- 6年前
概览
简要总结
Recorded cutaneous ECG containing arrhythmia events are separately analysed by an expert Electrophysiologist and the ISSD detection algorithm, to allow assessment of the correct detection of tachyarrhythmia events and discrimination of supra-ventricular arrhythmia of the algorithm,m compared to the expert.
详细描述
cutaneous ECG electrodes positioned near the sternum and on the midaxillary line, at the approximate positions of the ISSD sense electrodes, are used to record patients undergoing Defibrillation Threshold (DFT) studies or Electrophysiology (EP) studies of different types. Two separate copies of the recordings undergo parallel and separate analysis: one is sent to an expert Electrophysiologist for determination and classification of arrhythmia events of at least 5 seconds and at least 170 beats per minute. the other is fed to the ISSD detection algorithm, with a low cutoff rate of 170 beats per minute. the results are compared to establish the accuracy of the detection algorithm and the rate of false detection / classification of arrhythmia events.
研究者
入排标准
入选标准
- •candidate for ICD implantation
- •candidate for an ICD DFT study
- •candidate for an EP study
排除标准
- 未提供
结局指标
主要结局
ISSD algorithm detection rates
时间窗: through study completion, expected at 15 months
Calculation of the ISSD algorithm detection and classification rates, compared to an EP expert analysis of the ECG traces