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

NCT05196412 | Completed

• 1 other identifier: AinoScreening
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Arrhythmias, Cardiac; Atrial Fibrillation

Keywords

Wearable; Wrist-worn

Outcome Measures

Primary Outcomes (3)

• Diagnostic performance improvement with continuous optical measurement

  Percentual improvement in the performance of detecting previously undiagnosed atrial fibrillation in the study population by the continuous PPG-based heartbeat interval monitoring when compared with relying only on scheduled and symptom -based ECG measurements. Cardiac rhythm assessed by a cardiologist from the ECG measurements that are made as a result of PPG-based arrhythmia notifications is compared with rhythm assessments made only from the scheduled and symptom-based ECG measurements. It is evaluated whether more subjects can be diagnosed having atrial fibrillation with the help of continuous PPG-based rhythm monitoring.

  Duration of patient measurement, i.e. two weeks

• Validation of the clinical performance of PulseOn Arrhythmia Monitor System in general population by showing the adequacy of the obtained ECG data for clinical decision making.

  Data recorded by the study subjects during the two-week study time is assessed by a cardiologist and subjects are classified as having: "no observed arrhythmias", "atrial fibrillation episode(s)", "other potential arrhythmia", or "unconfident assessment" (due to the quality or lack of data). The percentage of "unconfident assessment" shall be less than 20% of the subjects.

  Duration of patient measurement, i.e. two weeks

• Validation of the clinical performance of PulseOn Arrhythmia Monitor System in general population by showing sufficient patient convenience for using the device for the intended duration of two weeks

  The feedback from the subjects should show at least grade 3 in a scale of 1-5 for the "comfortability of using the wrist device".

  Duration of patient measurement, i.e. two weeks

Secondary Outcomes (8)

• Showing the benefit of the combined wrist-worn PPG and ECG solution in detecting other cardiac arrhythmias than atrial fibrillation.

  Duration of patient measurement, i.e. two weeks

• Evaluation of the necessity of performing scheduled ECG measurements in addition to ECG measurements triggered by PPG-based arrhythmia notifications for detecting atrial fibrillation.

  Duration of patient measurement, i.e. two weeks

• Feedback about the usability of the evaluated solution from study subjects.

  At the end of the 2-week measurement period

• Feedback about the usability of the evaluated solution from study personnel.

  At the end of the study i.e. the end of 2022.

• Quality of the measured ECG signals

  Duration of patient measurement, i.e. two weeks

Study Arms (2)

Main study group

EXPERIMENTAL

Normal subjects of at least 65 years of age

Device: PulseOn Arrhythmia Monitor device

Endurance athlete group

EXPERIMENTAL

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

Device: PulseOn Arrhythmia Monitor device

Interventions

PulseOn Arrhythmia Monitor device DEVICE

Wearing of the wrist device for a period of two weeks

Endurance athlete group; Main study group

Eligibility Criteria

• Age: 50 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Cardiac pacemaker
• Earlier diagnosis of atrial fibrillation
• Inability to give informed consent
• Denial

Sponsors & Collaborators

• PulseOn Oy: lead
• TAYS Sydänkeskus Oy: collaborator
• Atostek Oy: collaborator

Study Sites (1)

Tampere Heart Hospital

Tampere, Finland

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac; Atrial Fibrillation

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Vesa Virtanen, PhD (med)

  Heart Hospital of Tampere University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2021
• First Posted: January 19, 2022
• Study Start: May 22, 2022
• Primary Completion: July 10, 2023
• Study Completion: July 10, 2023
• Last Updated: August 27, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)