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Clinical Validation of the Electrocardiogram Measurement

NCT05830578 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 602

Last updated 2023-11-24

No results posted yet for this study

Summary

Atrial fibrillation (AFib) is a common type of cardiac arrhythmia in clinical practice, affecting millions of people worldwide. Early detection and treatment of atrial fibrillation are crucial in preventing serious complications such as stroke and heart failure. In recent years, with the flourishing development of wearable devices and mobile technology, electrocardiogram (ECG) measurement applications embedded in smartwatches have gradually become a non-invasive and convenient method for heart rate monitoring. However, the accuracy of these devices has not yet been fully determined. This study aims to verify the ECG measurement and atrial fibrillation detection function of the ASUS Blood Pressure Monitor/Oximeter/ECG Monitor. The accuracy of the ECG application in detecting atrial fibrillation and measuring ECG will be evaluated by comparison with standard 12-lead ECGs.

Conditions

Interventions

DEVICE

ASUS Blood Pressure Monitor/Oximeter/ECG Monitor

The ASUS Blood Pressure Monitor/Oximeter/ECG Monitor analyzes data collected by the integrated electrical sensors on a ASUS Vivowatch to generate an ECG waveform similar to a Lead I, calculate average heart rate, and provide a rhythm classification to the user for a given 30 second session. When a user opens the ECG App while wearing the ASUS VivoWatch on one wrist and places the finger of the opposite hand on the digital crown, they are completing the circuit across the heart which begins a recording session. Once the recording session is complete, the ECG App performs signal processing, feature extraction and rhythm classification to generate a session result.

Sponsors & Collaborators

  • Taipei Medical University Hospital

    lead OTHER

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-12-01
Primary Completion
2024-06-30
Completion
2024-12-30

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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 NCT05830578 on ClinicalTrials.gov