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Completed

NCT Number: NCT05196412

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

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.

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Key information

Conditions

Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

50 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tampere Heart Hospital

Tampere, Finland

About this study

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:

  • Scheduled recording four times a day
  • In case of suspecting arrhythmic event, i.e. feeling symptoms
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PulseOn Arrhythmia Monitor device

Device

Wearing of the wrist device for a period of two weeks

Primary outcomes

  1. Diagnostic performance improvement with continuous optical measurement

    Time frame: Duration of patient measurement, i.e. two weeks

    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.

  2. 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.

    Time frame: Duration of patient measurement, i.e. two weeks

    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.

  3. 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

    Time frame: Duration of patient measurement, i.e. 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".

Secondary outcomes

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

    Time frame: Duration of patient measurement, i.e. two weeks

    The visual ECG-based rhythm annotation made by a cardiologist is compared with simultaneous PPG-algorithm alarm state. The incidence of notifications for other arrhythmias than atrial fibrilation is reported.

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

    Time frame: Duration of patient measurement, i.e. two weeks

    Evaluation is done by comparing the atrial fibrillation detection outcome when considering only the PPG-triggered and symptom-based ECG measurements or when considering also the scheduled ECG measurements. The outcome parameter is the number of subjects that would have been left undetected if the scheduled ECG measurements were not taken.

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

    Time frame: At the end of the 2-week measurement period

    Feedback questions in scale of 1-5 and open-ended feedback. Easiness of use of the wrist device, understandability of the user interface, suitability of the user materials, and unobtrusiveness.

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

    Time frame: At the end of the study i.e. the end of 2022.

    Feedback questions in scale of 1-5 and open-ended feedback. Easiness of use of the data management service, suitability of the user materials.

  5. Quality of the measured ECG signals

    Time frame: Duration of patient measurement, i.e. two weeks

    Percentage of the ECG measurements classified as inadequate quality for rhythm assessment either an ECG analysis algorithm or by a doctor.

  6. Assessment of the subjects' adherence in using the solution.

    Time frame: Duration of patient measurement, i.e. two weeks

    Analysis of how well the participants will follow the study protocol and do the participants register their ECG in correlation with the wrist device notification. The outcome parameter is the percentage of scheduled and PPG-based notifications to take an ECG measurement and the variation of the percentage between the subjects.

  7. Benefit of optical measurement for the speed of detecting atrial fibrillation

    Time frame: Duration of patient measurement, i.e. two weeks

    Comparison of the time to the first detection of atrial fibrillation or other arrhythmia when considering PPG-triggered ECG measurements or when considering the scheduled ECG measurements.

  8. Evaluation of the accuracy of automatic ECG analysis algorithms when comparing with manual annotations by a cardiologist.

    Time frame: Duration of patient measurement, i.e. two weeks

    The automated assessment done for the 30-second ECG recordings is compared with the visual assessment to calculate the sensitivity and specificity for each rhythm category.

Sponsors and collaborators

Lead sponsor

PulseOn Oy

Industry

Collaborators

  • Atostek Oy
  • TAYS Sydänkeskus Oy

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 19, 2022
Registry last updated
Aug 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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