Aino ECG Ambulatory Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

31 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-01

Study Completion Date

2021-08-01

Brief Summary

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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.

Detailed Description

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Conditions

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Arrhythmias, Cardiac Atrial Fibrillation and Flutter

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Wrist-word optical heart rate and ECG measurement device

Aino ECG: wrist-word optical heart rate and ECG measurement device

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Implanted permanent pacemaker
* Inability to give informed consent e.g. due to mental confusion
* Denial

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jussi Hernesniemi, Docent

Role: PRINCIPAL_INVESTIGATOR

Tampere Heart Hospital

Locations

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Tampere Heart Hospital

Tampere, , Finland

Site Status

Countries

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Finland

References

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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.

Reference Type DERIVED

PMID: 36844740 (View on PubMed)

Other Identifiers

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