Cardiac arrhythmias
Conditions
Interventions
None listed
Sponsors
Huawei Device Co., Ltd
Eligibility
Age
18 Years to 99 Years
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitivity and specificity of a series of three measurements to detect atrial fibrillation, premature heart rate and sinus rhythm. a. Sensitivity and Specificity of Atrial Fibrillation Recognition b. Sensitivity and Specificity of Premature Heart Rate Recognition c. Sensitivity and specificity for identifying sinus rhythms. | — |
Secondary
| Measure | Time frame |
|---|---|
| Performance Endpoints To measure the sensitivity and specificity of three consecutive measurements and of a single measurement to detect atrial fibrillation, premature heartbeat and sinus rhythm, single measurement results from arrhythmia analysis software are compared with the interpretation results from the simultaneous ECG recording. Sensitivity and specificity of a single measurement to detect atrial fibrillation, premature heartbeat and sinus rhythm. a. Sensitivity and Specificity of Recognition of Atrial Fibrillation by Single Measurement b. Sensitivity and Specificity of Recognition of Premature Heart Rate by Single Measurement c. Sensitivity and specificity for identifying sinus rhythms in a single measurement Safety Endpoints To determine safety, software failure rates and the incidence of adverse and serious adverse events are recorded. 1. Software error rate (e.g. failures in getting a readout, delivering output, etc.) 2. Incidence of Device or Procedure Adverse and Serious Adverse Events | — |
Countries
Netherlands
Outcome results
None listed