Clinical Investigation to Evaluate the Effectiveness and Safety of ECG App

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.

Study Overview

• Status: Completed
• Conditions: Arrhythmias, Cardiac
• Intervention / Treatment: Device: 12-Lead ECG(I-lead)

• Study Type: Interventional
• Enrollment (Actual): 673
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • The First Medical Center of the Chinese PLA General Hospital & Medical School
  • Guangzhou, China
    • The First Affiliated Hospital of Sun Yat-Sen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

   1. Patients with normal sinus rhythm;
   2. Patients with persistent or permanent paroxysmal atrial fibrillation or in the onset of paroxysmal atrial fibrillation;
   3. Patients with frequent premature beats (more than 5 per minute) or in the onset of premature beats;
3. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Sensitivity and specificity of atrial fibrillation identification	30seconds
Sensitivity and specificity of premature beat identification	30seconds
Sensitivity and specificity of sinus rhythm identification	30seconds

Secondary Outcome Measures

Outcome Measure	Time Frame
Detection rate of ventricular premature beats and atrial premature beats	30seconds
Total coincidence rate of measurement and identification	30seconds
ECG waveform similarity	30seconds
R wave amplitude consistency	30seconds
Heart rate accuracy	30seconds
Software usability	30seconds

Other Outcome Measures

Outcome Measure	Time Frame
Software failure rate	30seconds
The incidence of adverse events and serious adverse events	30seconds

Collaborators and Investigators

• Sponsor: Huawei Device Co., Ltd
• Investigators: Principal Investigator: Guo Yutao, doctor, The First Medical Center of the Chinese PLA General Hospital & Medical School

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2021
• Primary Completion (Actual): September 30, 2021
• Study Completion (Actual): September 30, 2021

Study Registration Dates

• First Submitted: July 28, 2022
• First Submitted That Met QC Criteria: July 28, 2022
• First Posted (Actual): August 1, 2022

Study Record Updates

• Last Update Posted (Actual): August 2, 2022
• Last Update Submitted That Met QC Criteria: July 30, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac
• Other Study ID Numbers: HWECG-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No