Status:
UNKNOWN
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
Lead Sponsor:
Huawei Device Co., Ltd
Conditions:
Arrhythmia, Cardiac
Eligibility:
All Genders
18-100 years
Brief 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 (P...
Detailed Description
The purpose of this descriptive study is to describe Huawei's arrhythmia analysis software on PPG data collected with a wearable device (smartwatch or smart band) in people of light and dark skin tone...
Eligibility Criteria
Inclusion
- Age \>18 of any sex;
- Wrist circumference 140 mm - 210 mm;
- Fitzpatrick skin type 1, 2, 5, or 6 (pre-screening);
- Melanin Index (MI) \<150 or \>350 as measured on the inner arm;
- One of the following conditions, based on past 3 months' history or screening electrocardiogram:
- Normal sinus rhythm;
- Persistent or permanent or onset atrial fibrillation;
- Frequent (\>5 beats per minute) premature beats or ongoing premature beats;
- Willing and able to provide voluntary, written informed consent
Exclusion
- Patients using pacemakers or implantable cardioverter defibrillators (ICDs);
- Patients with atrioventricular block or bundle branch block;
- Patients with sinus tachycardia, significant sinus bradycardia, significant sinus arrhythmia, sinus arrest or sick sinus syndrome;
- Interpositional premature beats, dual-law premature beats, triple-law premature beats, border premature beats or escape beat heart rhythm patients;
- Patients with atrial tachycardia, atrial flutter, ventricular tachycardia, ventricular flutter or ventricular fibrillation;
- Patients with a resting heart rate less than 50 times/minute or more than 110 times/minute;
- Patients with tremor disease or chorea disease that are difficult to cooperate in completing the examination while remaining still;
- Bullous disease or generalized rash, and other patients not suitable for surface electrode recording;
- Patients with skin allergies to alcohol;
- Patients with skin infectious diseases;
- Patients with a history of mental illness or cognitive impairment;
- Patients who have participated in other clinical trials that may affect this trial within the past 30 days;
- Concomitant medication that might interfere with study results;
- Other situations where the researchers consider it inappropriate for a patient to take part in the trial.
Key Trial Info
Start Date :
April 21 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 21 2023
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT05437926
Start Date
April 21 2022
End Date
September 21 2023
Last Update
March 2 2023
Active Locations (1)
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1
Maasstad Hospital
Rotterdam, Netherlands, 3079 DZ