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A Study to Describe the Effectiveness of Arrhythmia Analysis Software for Screening of Sinus Rhythm, Atrial Fibrillation and Premature Beats in light-and Dark Skin Tone Patients

NCT05437926 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 102

Last updated 2023-03-02

No results posted yet for this study

Summary

The purpose of this study is to describe the Huawei'ssoftware ("Arrhythmia Analysis Software") for the detection of atrial fibrillation, premature beats, and sinus rhythm using photoplethysmography (PPG). Data derived from a wearable device with a PPG sensor (watch or band) in patients with light skin or dark skin tones will be used as an index test. The Huawei software is intended as a pre-screening technology. It should identify candidates who may benefit from further evaluation. The software is not intended to be a diagnostic system.

Conditions

  • Arrhythmia, Cardiac

Interventions

DEVICE

Arrhythmia Analysis Software (software) which runs on a mobile application (Huawei Phone) and uses input from a wearable device (smart watch or smart band).

Subjects with or without cardiac arrhythmias and of light skin tone (melanin index \<150) or dark skin tone (melanin index \>350). Subjects will be divided based on their heart rhythm in three groups: approximately 1/3 with normal sinus rhythm, 1/3 with atrial fibrillation and 1/3 with premature beats

Sponsors & Collaborators

  • Huawei Device Co., Ltd

    lead INDUSTRY

Eligibility

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

Timeline & Regulatory

Start
2022-04-21
Primary Completion
2023-07-21
Completion
2023-09-21

Countries

  • Netherlands

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 NCT05437926 on ClinicalTrials.gov