Detection of Cardiac Arrhythmias With Wrist-worn Combined Optical and ECG Based Heart Rate Monitor During Normal Daily Living
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Arrhythmias, Cardiac
- Sponsor
- PulseOn Oy
- Enrollment
- 31
- Locations
- 1
- Primary Endpoint
- Verification that the quality of the ECG signal measured with Aino ECG satisfies the design input requirement defined for the Aino ECG device.
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •Implanted permanent pacemaker
- •Inability to give informed consent e.g. due to mental confusion
Outcomes
Primary Outcomes
Verification that the quality of the ECG signal measured with Aino ECG satisfies the design input requirement defined for the Aino ECG device.
Time Frame: 6 months
Verification that the atrial fibrillation detection sensitivity satisfies the design input requirements defined for the Aino ECG device
Time Frame: 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.
Time Frame: 6 months
Secondary Outcomes
- 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)