A study to describe the effectiveness of arrhythmia analysis software for screening of Sinus rhythm, Atrial Fibrillation and premature beats in light skin-and dark skin tone patients

Completed

• Conditions: Cardiac arrhythmias; 10007521

• Registration Number: NL-OMON54431
• Lead Sponsor: Huawei Device Co., Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 84

Inclusion Criteria

1. Age >18 of any sex; 2. Wrist circumference 140 mm - 210 mm; 3.
Fitzpatrick skin type 1, 2, 5, or 6 (pre-screening); 4. Melanin Index (MI)
<150 or >350 as measured on the inner arm; 5. One of the following
conditions, based on past 3 months' history or screening electrocardiogram: a.
Normal sinus rhythm; b. Persistent or permanent or onset atrial fibrillation;
c. Frequent (>5 beats per minute) premature beats or ongoing premature
beats; 6. Willing and able to provide voluntary, written informed consent.

Exclusion Criteria

1. Patients using pacemakers or implantable cardioverter defibrillators (ICDs);
2. Patients with atrioventricular block or bundle branch block;
3. Patients with sinus tachycardia, significant sinus bradycardia, significant
sinus arrhythmia, sinus arrest or sick sinus syndrome;
4. Interpositional premature beats, dual-law premature beats, triple-law
premature beats, border premature beats or escape beat heart rhythm patients;
5. Patients with atrial tachycardia, atrial flutter, ventricular tachycardia,
ventricular flutter or ventricular fibrillation;
6. Patients with resting heart rate less than 50 times/minute or more than 110
times/minute;
7. Patients with tremor disease or chorea disease that are difficult to
cooperate in completing the examination while remaining still;
8. Bullous disease or generalized rash, and other patients not suitable for
surface electrode recording;
9. Patients with skin allergies to alcohol;
10. Patients with skin infectious diseases;
11. Patients with a history of mental illness or cognitive impairment;
12. Patients who have participated in other clinical trials that may affect
this trial within the past 30 days;
13. Concomitant medication that might interfere with study results;
14. Other situations where the researchers consider it inappropriate for a
patient to take part in the trial.

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Sensitivity and specificity of a series of three measurements to detect atrial<br /><br>fibrillation, premature heart rate and sinus rhythm.<br /><br>a. Sensitivity and Specificity of Atrial Fibrillation Recognition<br /><br>b. Sensitivity and Specificity of Premature Heart Rate Recognition<br /><br>c. Sensitivity and specificity for identifying sinus rhythms.</p><br>