Aino ECG Ambulatory Study

Completed

• Conditions: Atrial Fibrillation and Flutter; Arrhythmias, Cardiac

• Registration Number: NCT05008601
• Lead Sponsor: PulseOn Oy

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-01
• Study First Submitted: 2021-07-30
• Status Verified: 2021-08
• Primary Completion: 2021-08-01
• Study Completion: 2021-08-01
• Study First Submitted QC: 2021-08-09
• Study First Posted: 2021-08-17
• Last Update Submitted: 2021-11-16
• Last Update Posted: 2021-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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
• Denial

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Verification that the quality of the ECG signal measured with Aino ECG satisfies the design input requirement defined for the Aino ECG device.	6 months
Verification that the atrial fibrillation detection sensitivity satisfies the design input requirements defined for the Aino ECG device	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.	6 months

Secondary Outcome Measures

Name	Time	Method
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	The feedback is obtained with feedback form filled by the study participants. The form includes questions regarding: overall impression on the study device, easiness of noticing and interpret the notifications of the device, comfortability of using the device, easiness of adjusting the tightness of the wrist band, and operation of the intermittent ECG measurements.

Trial Locations

Locations (1)

Tampere Heart Hospital; 🇫🇮 Tampere, Finland