Arrhythmias, CardiacNCT05196412

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

A study testing PulseOn Arrhythmia Monitor device in people with Arrhythmias, Cardiac and Atrial Fibrillation, run by PulseOn Oy at 1 site in Finland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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… Read more about this study

Who is it for?: Ages 50 to 99 yearsHealthy volunteers can take part
Conditions the study is for: Arrhythmias, Cardiac, Atrial Fibrillation
What is being tested?: PulseOn Arrhythmia Monitor device
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 250 participants
Where: 1 siteFinland
Study dates: 22 May 2022to 10 Jul 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 to 99 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Show all 9Show fewer

Self-assessed ability to use the study devices
Ability to give informed consent
Volunteering for the study

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Finland1 site

Tampere Heart Hospital
Tampere

Other trials in Finland

About this study

Read the 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:

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.

Conditions: Arrhythmias, Cardiac, Atrial Fibrillation
Being tested: PulseOn Arrhythmia Monitor device
Keywords: Wearable, Wrist-worn
Medical subject headings: Arrhythmias, Cardiac, Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PulseOn Arrhythmia Monitor deviceDevice
Wearing of the wrist device for a period of two weeks

Study groups in NCT05196412
Study group	Role	What they receive
Main study group	Experimental	Normal subjects of at least 65 years of age Receives: Device: PulseOn Arrhythmia Monitor device
Endurance athlete group	Experimental	Group consists of active endurance athletes of at least 50 years of age Receives: Device: PulseOn Arrhythmia Monitor device

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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".
Measured: 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.
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.
Measured: 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.
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.
Measured: Duration of patient measurement, i.e. two weeks
Feedback about the usability of the evaluated solution from study subjects.
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.
Measured: At the end of the 2-week measurement period
Feedback about the usability of the evaluated solution from study personnel.
Feedback questions in scale of 1-5 and open-ended feedback. Easiness of use of the data management service, suitability of the user materials.
Measured: At the end of the study i.e. the end of 2022.
Quality of the measured ECG signals
Percentage of the ECG measurements classified as inadequate quality for rhythm assessment either an ECG analysis algorithm or by a doctor.
Measured: Duration of patient measurement, i.e. two weeks
Assessment of the subjects' adherence in using the solution.
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.
Measured: Duration of patient measurement, i.e. two weeks
Benefit of optical measurement for the speed of detecting atrial fibrillation
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.
Measured: Duration of patient measurement, i.e. two weeks
Evaluation of the accuracy of automatic ECG analysis algorithms when comparing with manual annotations by a cardiologist.
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.
Measured: Duration of patient measurement, i.e. two weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 May 202210 Jul 2023

First posted19 Jan 2022
Study start22 May 2022
Primary completion10 Jul 2023
Study completion10 Jul 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Arrhythmias, CardiacStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Screening
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 250 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05196412
Sponsor's protocol ID: AinoScreening
Status last verified: Aug 2024
First submitted: 18 Nov 2021
Last updated: 27 Aug 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Not yet recruiting
Smartphone Camera Measurement of Breathing-Related Heart Rate Variability Compared With ECG in Healthy Adults
Respiratory Sinus Arrhythmia, Heart Rate Variability
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation

All Arrhythmias, Cardiac trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Screening of Cardiac Arrhythmias With Wrist-worn Aino ECG Cardiac Monitor
ClinicalTrials.gov ID: NCT05196412
Acronym / sponsor ID: AinoScreening
Conditions: Arrhythmias, Cardiac, Atrial Fibrillation
Keywords: Wearable, Wrist-worn
Study type: Interventional
Recruitment status: Completed
Enrolment: 250 participants (actual)
Lead sponsor: PulseOn OyIndustry (pharma, biotech, devices)
Collaborators: TAYS Sydänkeskus Oy, Atostek Oy
Study start: 22 May 2022 (actual)
Primary completion: 10 Jul 2023 (actual)
Study completion: 10 Jul 2023 (actual)
First posted: 19 Jan 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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.

Study design

Primary purpose: Screening
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Main study group	Experimental	Device: PulseOn Arrhythmia Monitor deviceNormal subjects of at least 65 years of age
Endurance athlete group	Experimental	Device: PulseOn Arrhythmia Monitor deviceGroup consists of active endurance athletes of at least 50 years of age

Who may qualify

Ages: 50 to 99 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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.

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PulseOn Arrhythmia Monitor deviceWearing of the wrist device for a period of two weeks	Device	Endurance athlete group, Main study group

Primary outcome

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.
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.
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".

8 secondary outcomes

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
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
Feedback about the usability of the evaluated solution from study subjects.
Time frame: At the end of the 2-week measurement period
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.
Quality of the measured ECG signals
Time frame: Duration of patient measurement, i.e. two weeks
Assessment of the subjects' adherence in using the solution.
Time frame: Duration of patient measurement, i.e. two weeks
Benefit of optical measurement for the speed of detecting atrial fibrillation
Time frame: Duration of patient measurement, i.e. two weeks
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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
Individual participant dataSharing planned: No

Related trials for Arrhythmias, Cardiac

RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Not yet recruiting
Smartphone Camera Measurement of Breathing-Related Heart Rate Variability Compared With ECG in Healthy Adults
Respiratory Sinus Arrhythmia, Heart Rate Variability
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Vesa Virtanen, PhD (med) principal investigator

Heart Hospital of Tampere University Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing PulseOn Arrhythmia Monitor device in people with Arrhythmias, Cardiac and Atrial Fibrillation, run by PulseOn Oy at 1 site in Finland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Diagnostic performance improvement with continuous optical measurement (time frame: Duration of patient measurement, i.e. two weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05196412.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2024.