Clinical trial NCT05196412: Screening of Cardiac Arrhythmias With Wrist-worn Aino ECG Cardiac Monitor
Official title: Screening of Cardiac Arrhythmias With Wrist-worn Aino ECG Cardiac Monitor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arrhythmias, Cardiac
Atrial Fibrillation
Keywords: Wearable
Wrist-worn
Lead sponsor: PulseOn Oy
Sponsor class: INDUSTRY
Collaborators: name: TAYS Sydänkeskus Oy
name: Atostek Oy
First posted: 2022-01-19
Enrollment: 250
Sex: ALL
Minimum age (years): 50
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The study investigates the performance pf PulseOn Arrhythmia Monitor System that includes a wrist-worn device, which combines continuous optical heartbeat interval monitoring and intermittent ECG measurement, and a data management system used by healthcare professionals for data observation, in the detection of previously undiagnosed cardiac arrhythmias, especially atrial fibrillation.

Detailed description: The study consists of monitoring voluntary subjects with PulseOn Arrhythmia Monitoring System for the period of two weeks. The subjects are recruited mainly through newspaper advertisements. The study is executed in Tampere and Helsinki areas, Finland.

During the two week monitoring time, the subjects are instructed to wear the wrist device continuously, except when taking the device off e.g. for going to sauna or swimming, and for charging. The subjects are instructed to perform a 35-second ECG measurement (recording) in three cases:

1. Scheduled recording four times a day
2. In case of suspecting arrhythmic event, i.e. feeling symptoms
3. In case the wrist device instructs to perform a recording by vibrating and showing an LED light

The data collected in the study is analysed post-hoc. In the post-hoc analysis, the cardiac rhythm assessed automatically from the ECG measurements is visually confirmed by a cardiologist.

Eligibility criteria: Inclusion Criteria for the main study group:

* At least 65 years of age
* Self-assessed ability to use the study devices
* Ability to give informed consent
* Volunteering for the study

Inclusion criteria for the active endurance athlete group:

* Minimum of 10 years of active training of endurance sport (e.g. long distance running, skiing, cycling, triathlon...) and currently an average amount of training of at least 10 hours a week.
* Age: ≥ 50 years
* Self-assessed ability to use the study devices
* Ability to give informed consent
* Volunteering for the study

Exclusion Criteria for both groups:

* Cardiac pacemaker
* Earlier diagnosis of atrial fibrillation
* Inability to give informed consent
* Denial

Primary outcomes:
measure: Diagnostic performance improvement with continuous optical measurement
timeFrame: Duration of patient measurement, i.e. two weeks
measure: Validation of the clinical performance of PulseOn Arrhythmia Monitor System in general population by showing the adequacy of the obtained ECG data for clinical decision making.
timeFrame: Duration of patient measurement, i.e. two weeks
measure: Validation of the clinical performance of PulseOn Arrhythmia Monitor System in general population by showing sufficient patient convenience for using the device for the intended duration of two weeks
timeFrame: Duration of patient measurement, i.e. two weeks
Secondary outcomes:
measure: Showing the benefit of the combined wrist-worn PPG and ECG solution in detecting other cardiac arrhythmias than atrial fibrillation.
timeFrame: Duration of patient measurement, i.e. two weeks
measure: Evaluation of the necessity of performing scheduled ECG measurements in addition to ECG measurements triggered by PPG-based arrhythmia notifications for detecting atrial fibrillation.
timeFrame: Duration of patient measurement, i.e. two weeks
measure: Feedback about the usability of the evaluated solution from study subjects.
timeFrame: At the end of the 2-week measurement period
measure: Feedback about the usability of the evaluated solution from study personnel.
timeFrame: At the end of the study i.e. the end of 2022.
measure: Quality of the measured ECG signals
timeFrame: Duration of patient measurement, i.e. two weeks
measure: Assessment of the subjects' adherence in using the solution.
timeFrame: Duration of patient measurement, i.e. two weeks
measure: Benefit of optical measurement for the speed of detecting atrial fibrillation
timeFrame: Duration of patient measurement, i.e. two weeks
measure: Evaluation of the accuracy of automatic ECG analysis algorithms when comparing with manual annotations by a cardiologist.
timeFrame: Duration of patient measurement, i.e. two weeks
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Tampere Heart Hospital
Study officials:
affiliation: Heart Hospital of Tampere University Hospital
name: Vesa Virtanen, PhD (med)
role: PRINCIPAL_INVESTIGATOR
References: