Screening of Cardiac Arrhythmias With Wrist-worn Aino ECG Cardiac Monitor

PulseOn

Status: Completed

Conditions: Atrial Fibrillation; Arrhythmias, Cardiac

Treatments: Device: PulseOn Arrhythmia Monitor device

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT05196412

AinoScreening

Details and patient eligibility

About

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.

Full 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.

Enrollment: 250 patients

Sex: All

Ages: 50 to 99 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 2 patient groups

Main study group

Experimental group

Description:

Normal subjects of at least 65 years of age

Treatment:

Device: PulseOn Arrhythmia Monitor device

Endurance athlete group

Experimental group

Description:

Group consists of active endurance athletes of at least 50 years of age

Treatment:

Device: PulseOn Arrhythmia Monitor device