Clinical trial NCT05008601: Aino ECG Ambulatory Study
Official title: Detection of Cardiac Arrhythmias With Wrist-worn Combined Optical and ECG Based Heart Rate Monitor During Normal Daily Living
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arrhythmias, Cardiac
Atrial Fibrillation and Flutter
Lead sponsor: PulseOn Oy
Sponsor class: INDUSTRY
Collaborators: name: TAYS Sydänkeskus Oy
name: Atostek Oy
First posted: 2021-08-17
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The source population of the study includes patients referred to a therapeutic evaluation or treatment in Tays Heart Hospital due to suspected cardiac arrhythmia. A portion (up to one third) of the subjects may be having on-going atrial fibrillation at the beginning of the measurement and may suffer from persistent or permanent atrial fibrillation.

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.


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
* Denial

Primary outcomes:
measure: Verification that the atrial fibrillation detection sensitivity satisfies the design input requirements defined for the Aino ECG device
timeFrame: 6 months
measure: Verification that the data accuracy (accuracy of optically measured inter-beat-intervals) satisfies the design input requirement defined for the Aino ECG device.
timeFrame: 6 months
measure: Verification that the quality of the ECG signal measured with Aino ECG satisfies the design input requirement defined for the Aino ECG device.
timeFrame: 6 months
Secondary outcomes:
measure: Showing that the quality of the measured PPG signal is similar enough compared with the one measured with the earlier prototype
timeFrame: 6 months
measure: To obtain feedback regarding the usability of the Aino ECG wrist device
timeFrame: 6 months
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Tampere Heart Hospital
Study officials:
affiliation: Tampere Heart Hospital
name: Jussi Hernesniemi, Docent
role: PRINCIPAL_INVESTIGATOR
References: