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Aino ECG Ambulatory Study

NCT05008601 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 31

Last updated 2021-11-17

No results posted yet for this study

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. 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.

Conditions

  • Arrhythmias, Cardiac
  • Atrial Fibrillation and Flutter

Interventions

DEVICE

Wrist-word optical heart rate and ECG measurement device

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

Sponsors & Collaborators

  • TAYS Sydänkeskus Oy

    collaborator UNKNOWN

  • Atostek Oy

    collaborator UNKNOWN

  • PulseOn Oy

    lead INDUSTRY

Principal Investigators

  • Jussi Hernesniemi, Docent · Tampere Heart Hospital

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-01
Primary Completion
2021-08-01
Completion
2021-08-01

Countries

  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05008601 on ClinicalTrials.gov