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Clinical Trials/NL-OMON54431
NL-OMON54431
Completed
N/A

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 - Huawei Afib study

Huawei Device Co., Ltd0 sites84 target enrollmentTBD
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Overview

Phase
N/A
Intervention
Not specified
Conditions
Not specified
Sponsor
Huawei Device Co., Ltd
Enrollment
84
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Observational non invasive

Investigators

Eligibility Criteria

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;

Outcomes

Primary Outcomes

Not specified

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