NCT05196412

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 250 (actual)
• Sponsor: PulseOn Oy · Industry
• Sex: All
• Age: 50 Years – 99 Years
• Healthy volunteers: Accepted

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.

Conditions

• Arrhythmias, Cardiac
• Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	PulseOn Arrhythmia Monitor device	Wearing of the wrist device for a period of two weeks

Timeline

• Start date: 2022-05-22
• Primary completion: 2023-07-10
• Completion: 2023-07-10
• First posted: 2022-01-19
• Last updated: 2024-08-27

Locations

1 site across 1 country: Finland