Clinical Investigation to Evaluate the Effectiveness and Safety of ECG App

Last updated: July 30, 2022
Sponsor: Huawei Device Co., Ltd
Overall Status: Completed

Phase

N/A

Condition

Circulation Disorders

Treatment

N/A

Clinical Study ID

NCT05482503
HWECG-001
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The purpose of this study is to verify the effectiveness and safety of the Huawei Device software (ECG APP), which can be used to analyze, store and display the ECG data transmitted by the single-lead ECG acquisition device. The software can be used for the analysis of sinus rhythm, atrial fibrillation, and premature beats(ventricular premature beats and atrial premature beats) in adults.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients over 18 years old, regardless of gender;
  2. Participants who meet one of the following conditions according to the medical historyin the past 3 months or the ECG during the screening period:
  3. Patients with normal sinus rhythm;
  4. Patients with persistent or permanent paroxysmal atrial fibrillation or in theonset of paroxysmal atrial fibrillation;
  5. Patients with frequent premature beats (more than 5 per minute) or in the onsetof premature beats;
  6. 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:

  1. Patients using cardiac pacemakers or implantable cardioverter defibrillators (ICD);
  2. Patients with atrioventricular block or bundle branch block;
  3. Patients with significant sinus arrhythmia, sinus arrest or sick sinus syndrome;
  4. Patients with interpolated premature beats, junctional premature beats, or escaperhythms;
  5. Patients with atrial tachycardia, atrial flutter, ventricular tachycardia, ventricularflutter, or ventricular fibrillation;
  6. Patients with a resting heart rate of slower than 50 beats/minute or faster than 110beats/minute;
  7. Patients with atrial fibrillation complicated with premature beats;
  8. Patients who are critically ill, making it difficult to make an accurate assessment ofthe effectiveness and safety of the device;
  9. Patients who suffer from tremor diseases or chorea, making it difficult to completethe examination quietly;
  10. Patients with bullous diseases or large-area skin rashes that are not suitable forbody surface electrode recording;
  11. Patients whose skin is allergic to ethanol;
  12. Patients with contagious skin diseases;
  13. Patients with a history of mental illness or with cognitive impairment;
  14. 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,
    China

    Site Not Available

  • The First Affiliated Hospital of Sun Yat-sen University

    Guangzhou,
    China

    Site Not Available

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