Arrhythmias, CardiacNCT05008601
Aino ECG Ambulatory Study
An observational study of Arrhythmias, Cardiac and Atrial Fibrillation and Flutter, run by PulseOn Oy at 1 site in Finland.
Trial summary
The study includes collection of data from patients referred to a therapeutic evaluation in Tays Sydänkeskus Oy (Heart Center Co, Tampere University Hospital) or another unit of Sydänkeskus (hereafter the Heart Hospital) due to suspected cardiac arrhythmia. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Arrhythmias, Cardiac, Atrial Fibrillation and Flutter
- What is being tested?
- Wrist-word optical heart rate and ECG measurement device
- Type of treatment
- Medical device
- How many people
- 31 participants
- Where
- 1 siteFinland
- Study dates
- 1 Apr 2021to 1 Aug 2021
- Phase
- Observational
- 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The source population of the study includes patients referred to a therapeutic evaluation or treatment in Tays Heart Hospital due to suspected cardiac arrhythmia. A portion (up to one third) of the subjects may be having on-going atrial fibrillation at the beginning of the measurement and may suffer from persistent or permanent atrial fibrillation.
Who may be able to join
- Age: ≥ 18 years
- Suspected or earlier diagnosed episodic cardiac arrhythmia, for example atrial fibrillation or atrial flutter
- Ability to give informed consent
- Volunteering for the study
Who cannot join
- Implanted permanent pacemaker
- Inability to give informed consent e.g. due to mental confusion
- Denial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Detection of Cardiac Arrhythmias With Wrist-worn Combined Optical and ECG Based Heart Rate Monitor During Normal Daily Living
The study includes collection of data from patients referred to a therapeutic evaluation in Tays Sydänkeskus Oy (Heart Center Co, Tampere University Hospital) or another unit of Sydänkeskus (hereafter the Heart Hospital) due to suspected cardiac arrhythmia. Data collection takes place outside the hospital in normal daily conditions. The monitoring is started during the outpatient visit at Heart hospital polyclinic or when leaving home from cardiac ward and it continues for 2 days. Reference information about the occurrence of arrhythmia episodes and the reference ECG data are obtained from simultaneously worn Holter device.
During the two days the study device and the reference device are worn continuously. Wearing the devices does not affect the daily routines of the participant except there is no possibility to take a shower. The arrhythmia episodes are labelled in post-hoc signal analysis and annotations visually confirmed by a cardiologist. The participants are instructed to take ECG recordings with the wrist device every time the device gives a notification and also whenever the participant feels arrhythmia symptoms. There will be at least four intermittent ECG records taken on each day.
- Being tested
- Wrist-word optical heart rate and ECG measurement device
- 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.
Wrist-word optical heart rate and ECG measurement deviceDevice
Aino ECG: wrist-word optical heart rate and ECG measurement device
What is being measured
The primary outcome is the main question the study is designed to answer.
Verification that the atrial fibrillation detection sensitivity satisfies the design input requirements defined for the Aino ECG device
Measured: 6 months
Verification that the data accuracy (accuracy of optically measured inter-beat-intervals) satisfies the design input requirement defined for the Aino ECG device.
Measured: 6 months
Verification that the quality of the ECG signal measured with Aino ECG satisfies the design input requirement defined for the Aino ECG device.
Measured: 6 months
Secondary outcomes (2)
Showing that the quality of the measured PPG signal is similar enough compared with the one measured with the earlier prototype
Measured: 6 months
To obtain feedback regarding the usability of the Aino ECG wrist device
The feedback is obtained with feedback form filled by the study participants. The form includes questions regarding: overall impression on the study device, easiness of noticing and interpret the notifications of the device, comfortability of using the device, easiness of adjusting the tightness of the wrist band, and operation of the intermittent ECG measurements.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2021
- Study start1 Apr 2021
- Primary completion1 Aug 2021
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- PulseOn Oy
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- TAYS Sydänkeskus Oy, Atostek Oy
- Responsible party
- Sponsor
- Investigators
- Jussi Hernesniemi, Docent, Principal investigator, Tampere Heart Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05008601
- Sponsor's protocol ID
- AinoECG_Ambulatory
- Status last verified
- Aug 2021
- First submitted
- 30 Jul 2021
- Last updated
- 17 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Saarinen HJ, Joutsen A, Korpi K, Halkola T, Nurmi M, Hernesniemi J, Vehkaoja A. Wrist-worn device combining PPG and ECG can be reliably used for atrial fibrillation detection in an outpatient setting. Front Cardiovasc Med. 2023 Feb 9;10:1100127. doi: 10.3389/fcvm.2023.1100127. eCollection 2023.
PubMed 36844740
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Cardiac Arrhythmias With Wrist-worn Combined Optical and ECG Based Heart Rate Monitor During Normal Daily Living
- ClinicalTrials.gov ID
- NCT05008601
- Acronym / sponsor ID
- AinoECG_Ambulatory
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- PulseOn OyIndustry (pharma, biotech, devices)
- Collaborators
- TAYS Sydänkeskus Oy, Atostek Oy
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 17 Aug 2021 (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.
The study includes collection of data from patients referred to a therapeutic evaluation in Tays Sydänkeskus Oy (Heart Center Co, Tampere University Hospital) or another unit of Sydänkeskus (hereafter the Heart Hospital) due to suspected cardiac arrhythmia. Data collection takes place outside the hospital in normal daily conditions. The monitoring is started during the outpatient visit at Heart hospital polyclinic or when leaving home from cardiac ward and it continues for 2 days. Reference information about the occurrence of arrhythmia episodes and the reference ECG data are obtained from simultaneously worn Holter device.
During the two days the study device and the reference device are worn continuously. Wearing the devices does not affect the daily routines of the participant except there is no possibility to take a shower. The arrhythmia episodes are labelled in post-hoc signal analysis and annotations visually confirmed by a cardiologist. The participants are instructed to take ECG recordings with the wrist device every time the device gives a notification and also whenever the participant feels arrhythmia symptoms. There will be at least four intermittent ECG records taken on each day.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The source population of the study includes patients referred to a therapeutic evaluation or treatment in Tays Heart Hospital due to suspected cardiac arrhythmia. A portion (up to one third) of the subjects may be having on-going atrial fibrillation at the beginning of the measurement and may suffer from persistent or permanent atrial fibrillation.
Key inclusion criteria (4 listed)
- Age: ≥ 18 years
- Suspected or earlier diagnosed episodic cardiac arrhythmia, for example atrial fibrillation or atrial flutter
- Ability to give informed consent
- Volunteering for the study
Key exclusion criteria (3 listed)
- Implanted permanent pacemaker
- Inability to give informed consent e.g. due to mental confusion
- 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 |
|---|---|---|
| Wrist-word optical heart rate and ECG measurement deviceAino ECG: wrist-word optical heart rate and ECG measurement device | Device | – |
Primary outcome
Verification that the atrial fibrillation detection sensitivity satisfies the design input requirements defined for the Aino ECG device
Time frame: 6 months
Verification that the data accuracy (accuracy of optically measured inter-beat-intervals) satisfies the design input requirement defined for the Aino ECG device.
Time frame: 6 months
Verification that the quality of the ECG signal measured with Aino ECG satisfies the design input requirement defined for the Aino ECG device.
Time frame: 6 months
2 secondary outcomes
Showing that the quality of the measured PPG signal is similar enough compared with the one measured with the earlier prototype
Time frame: 6 months
To obtain feedback regarding the usability of the Aino ECG wrist device
Time frame: 6 months
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 17 Nov 2021.
- Derived from this study: PubMed 36844740Saarinen HJ, Joutsen A, Korpi K, Halkola T, Nurmi M, Hernesniemi J, Vehkaoja A. Wrist-worn device combining PPG and ECG can be reliably used for atrial fibrillation detection in an outpatient setting. Front Cardiovasc Med. 2023 Feb 9;10:1100127. doi: 10.3389/fcvm.2023.1100127. eCollection 2023.
- Individual participant dataSharing planned: Undecided
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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.
Jussi Hernesniemi, Docent principal investigator
Tampere Heart Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arrhythmias, Cardiac and Atrial Fibrillation and Flutter, 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 4 inclusion and 3 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 17 Nov 2021. 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?
Verification that the atrial fibrillation detection sensitivity satisfies the design input requirements defined for the Aino ECG device (time frame: 6 months). 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 NCT05008601, which also lists 1 linked publication.
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 17 Nov 2021.