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临床试验/NCT05008601
NCT05008601已完成不适用

Detection of Cardiac Arrhythmias With Wrist-worn Combined Optical and ECG Based Heart Rate Monitor During Normal Daily Living

PulseOn Oy1 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2021年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
PulseOn Oy
入组人数
31
试验地点
1
主要终点
Verification that the quality of the ECG signal measured with Aino ECG satisfies the design input requirement defined for the Aino ECG device.

研究概览

简要总结

The study includes collection of data from patients referred to a therapeutic evaluation in Tays Sydänkeskus Oy (Heart Center Co, Tampere University Hospital) or another unit of Sydänkeskus (hereafter the Heart Hospital) due to suspected cardiac arrhythmia. Data collection takes place outside the hospital in normal daily conditions. The monitoring is started during the outpatient visit at Heart hospital polyclinic or when leaving home from cardiac ward and it continues for 2 days. Reference information about the occurrence of arrhythmia episodes and the reference ECG data are obtained from simultaneously worn Holter device.

During the two days the study device and the reference device are worn continuously. Wearing the devices does not affect the daily routines of the participant except there is no possibility to take a shower. The arrhythmia episodes are labelled in post-hoc signal analysis and annotations visually confirmed by a cardiologist. The participants are instructed to take ECG recordings with the wrist device every time the device gives a notification and also whenever the participant feels arrhythmia symptoms. There will be at least four intermittent ECG records taken on each day.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age: ≥ 18 years
  • Suspected or earlier diagnosed episodic cardiac arrhythmia, for example atrial fibrillation or atrial flutter
  • Ability to give informed consent
  • Volunteering for the study

排除标准

  • Implanted permanent pacemaker
  • Inability to give informed consent e.g. due to mental confusion

结局指标

主要结局

Verification that the quality of the ECG signal measured with Aino ECG satisfies the design input requirement defined for the Aino ECG device.

时间窗: 6 months

Verification that the atrial fibrillation detection sensitivity satisfies the design input requirements defined for the Aino ECG device

时间窗: 6 months

Verification that the data accuracy (accuracy of optically measured inter-beat-intervals) satisfies the design input requirement defined for the Aino ECG device.

时间窗: 6 months

次要结局

  • Showing that the quality of the measured PPG signal is similar enough compared with the one measured with the earlier prototype(6 months)
  • To obtain feedback regarding the usability of the Aino ECG wrist device(6 months)

研究者

发起方
PulseOn Oy
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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