Status:
COMPLETED
Screening of Cardiac Arrhythmias With Wrist-worn Aino ECG Cardiac Monitor
Lead Sponsor:
PulseOn Oy
Collaborating Sponsors:
TAYS Sydänkeskus Oy
Atostek Oy
Conditions:
Arrhythmias, Cardiac
Atrial Fibrillation
Eligibility:
All Genders
50-99 years
Phase:
NA
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 meas...
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 22 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 10 2023
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT05196412
Start Date
May 22 2022
End Date
July 10 2023
Last Update
August 27 2024
Active Locations (1)
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1
Tampere Heart Hospital
Tampere, Finland