Skip to main content
OpenTrials
Completed

NCT Number: NCT05008601

Aino ECG Ambulatory Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Tampere Heart Hospital

Tampere, Finland

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Wrist-word optical heart rate and ECG measurement device

Device

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

Primary outcomes

  1. Verification that the atrial fibrillation detection sensitivity satisfies the design input requirements defined for the Aino ECG device

    Time frame: 6 months

  2. 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

  3. 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

Secondary outcomes

  1. 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

  2. To obtain feedback regarding the usability of the Aino ECG wrist device

    Time frame: 6 months

    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.

Sponsors and collaborators

Lead sponsor

PulseOn Oy

Industry

Collaborators

  • Atostek Oy
  • TAYS Sydänkeskus Oy

Registry information

Official study title

Detection of Cardiac Arrhythmias With Wrist-worn Combined Optical and ECG Based Heart Rate Monitor During Normal Daily Living

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Aug 17, 2021
Registry last updated
Nov 17, 2021

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.