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Clinical Investigation to Evaluate the Effectiveness and Safety of ECG App

Sponsor
Huawei Device Co., Ltd (Industry)
Overall Status
Completed
CT.gov ID
NCT05482503
Collaborator
(none)
673
Enrollment
2
Locations
3
Arms
5.9
Actual Duration (Months)
336.5
Patients Per Site
56.6
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: 12-Lead ECG(I-lead)
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
673 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Diagnostic
Official Title:
Clinical Investigation to Evaluate the Effectiveness and Safety of ECG App
Actual Study Start Date :
Apr 2, 2021
Actual Primary Completion Date :
Sep 30, 2021
Actual Study Completion Date :
Sep 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Atrial Fibrillation

Device: 12-Lead ECG(I-lead)
All participants will simultaneously record 12-lead ECGs(I-lead)
Experimental: Premature beats

Device: 12-Lead ECG(I-lead)
All participants will simultaneously record 12-lead ECGs(I-lead)
Experimental: Sinus Rhythm

Device: 12-Lead ECG(I-lead)
All participants will simultaneously record 12-lead ECGs(I-lead)

Outcome Measures

Primary Outcome Measures

  1. Sensitivity and specificity of atrial fibrillation identification [30seconds]

  2. Sensitivity and specificity of premature beat identification [30seconds]

  3. Sensitivity and specificity of sinus rhythm identification [30seconds]

Secondary Outcome Measures

  1. Detection rate of ventricular premature beats and atrial premature beats [30seconds]

  2. Total coincidence rate of measurement and identification [30seconds]

  3. ECG waveform similarity [30seconds]

  4. R wave amplitude consistency [30seconds]

  5. Heart rate accuracy [30seconds]

  6. Software usability [30seconds]

Other Outcome Measures

  1. Software failure rate [30seconds]

  2. The incidence of adverse events and serious adverse events [30seconds]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  1. Patients over 18 years old, regardless of gender;

  2. Participants who meet one of the following conditions according to the medical history in 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 the onset of paroxysmal atrial fibrillation;

  5. Patients with frequent premature beats (more than 5 per minute) or in the onset of premature beats;

  6. Patients who have good compliance, and can cooperate to complete this research by himself/herself; 4）Patients who volunteer to participate and have signed an informed consent form.

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 escape rhythms;

  5. Patients with atrial tachycardia, atrial flutter, ventricular tachycardia, ventricular flutter, or ventricular fibrillation;

  6. Patients with a resting heart rate of slower than 50 beats/minute or faster than 110 beats/minute;

  7. Patients with atrial fibrillation complicated with premature beats;

  8. Patients who are critically ill, making it difficult to make an accurate assessment of the effectiveness and safety of the device;

  9. Patients who suffer from tremor diseases or chorea, making it difficult to complete the examination quietly;

  10. Patients with bullous diseases or large-area skin rashes that are not suitable for body 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 30 days that may affect this investigation; 15） Other conditions that the investigators consider inappropriate for participation in the investigation.

Contacts and Locations

Locations

Site City State Country Postal Code
1 The First Medical Center of the Chinese PLA General Hospital & Medical School Beijing China
2 The First Affiliated Hospital of Sun Yat-sen University Guangzhou China

Sponsors and Collaborators

  • Huawei Device Co., Ltd

Investigators

  • Principal Investigator: Guo Yutao, doctor, The First Medical Center of the Chinese PLA General Hospital & Medical School

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Huawei Device Co., Ltd
ClinicalTrials.gov Identifier:
NCT05482503
Other Study ID Numbers:
  • HWECG-001
First Posted:
Aug 1, 2022
Last Update Posted:
Aug 2, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Arrhythmias, Cardiac

Study Results

No Results Posted as of Aug 2, 2022