Last updated: July 30, 2022
Sponsor: Huawei Device Co., Ltd
Overall Status: Completed
Phase
N/A
Condition
Circulation Disorders
Treatment
N/AClinical Study ID
NCT05482503
HWECG-001
Ages > 18 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patients over 18 years old, regardless of gender;
- Participants who meet one of the following conditions according to the medical historyin the past 3 months or the ECG during the screening period:
- Patients with normal sinus rhythm;
- Patients with persistent or permanent paroxysmal atrial fibrillation or in theonset of paroxysmal atrial fibrillation;
- Patients with frequent premature beats (more than 5 per minute) or in the onsetof premature beats;
- Patients who have good compliance, and can cooperate to complete this research byhimself/herself; 4)Patients who volunteer to participate and have signed an informedconsent form.
Exclusion
Exclusion Criteria:
- Patients using cardiac pacemakers or implantable cardioverter defibrillators (ICD);
- Patients with atrioventricular block or bundle branch block;
- Patients with significant sinus arrhythmia, sinus arrest or sick sinus syndrome;
- Patients with interpolated premature beats, junctional premature beats, or escaperhythms;
- Patients with atrial tachycardia, atrial flutter, ventricular tachycardia, ventricularflutter, or ventricular fibrillation;
- Patients with a resting heart rate of slower than 50 beats/minute or faster than 110beats/minute;
- Patients with atrial fibrillation complicated with premature beats;
- Patients who are critically ill, making it difficult to make an accurate assessment ofthe effectiveness and safety of the device;
- Patients who suffer from tremor diseases or chorea, making it difficult to completethe examination quietly;
- Patients with bullous diseases or large-area skin rashes that are not suitable forbody surface electrode recording;
- Patients whose skin is allergic to ethanol;
- Patients with contagious skin diseases;
- Patients with a history of mental illness or with cognitive impairment;
- Patients who have participated in other clinical investigations within the past 30days that may affect this investigation; 15) Other conditions that the investigatorsconsider inappropriate for participation in the investigation.
Study Design
Total Participants: 673
Study Start date:
April 02, 2021
Estimated Completion Date:
September 30, 2021
Connect with a study center
The First Medical Center of the Chinese PLA General Hospital & Medical School
Beijing,
ChinaSite Not Available
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou,
ChinaSite Not Available

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