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

NCT ID: NCT05196412

Last Updated: 2024-08-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-22
• Study Completion Date: 2023-07-10

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.

Conditions

Arrhythmias, Cardiac; Atrial Fibrillation

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Main study group

Normal subjects of at least 65 years of age

Group Type: EXPERIMENTAL

PulseOn Arrhythmia Monitor device

Intervention Type: DEVICE

Wearing of the wrist device for a period of two weeks

Endurance athlete group

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

Group Type: EXPERIMENTAL

PulseOn Arrhythmia Monitor device

Intervention Type: DEVICE

Wearing of the wrist device for a period of two weeks

Interventions

PulseOn Arrhythmia Monitor device

Wearing of the wrist device for a period of two weeks

Intervention Type: DEVICE

Eligibility Criteria

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

• 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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

TAYS Sydänkeskus Oy

UNKNOWN

Sponsor Role: collaborator

Atostek Oy

UNKNOWN

Sponsor Role: collaborator

PulseOn Oy

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vesa Virtanen, PhD (med)

Role: PRINCIPAL_INVESTIGATOR

Heart Hospital of Tampere University Hospital

Locations

Tampere Heart Hospital

Tampere, , Finland

Countries

Finland

Other Identifiers

AinoScreening

Identifier Type: -

Identifier Source: org_study_id