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

  • STATUS
    Recruiting
  • days left to enroll
    30
  • participants needed
    200
  • sponsor
    PulseOn Oy
Updated on 14 June 2022
arrhythmia
fibrillation
cardiac monitoring
Accepts healthy volunteers

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.

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.

Details
Condition Arrhythmias, Cardiac, Atrial Fibrillation
Treatment PulseOn Arrhythmia Monitor device
Clinical Study IdentifierNCT05196412
SponsorPulseOn Oy
Last Modified on14 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Cardiac pacemaker
Earlier diagnosis of atrial fibrillation
Inability to give informed consent
Denial
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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