Clinical Investigation to Evaluate the Effectiveness and Safety of ECG App

Arrhythmias, Cardiac Clinical Trial

Official title:

Clinical Investigation to Evaluate the Effectiveness and Safety of ECG App

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05482503
• Other study ID #: HWECG-001
• Status: Completed
• Phase: N/A
• Start date: April 2, 2021
• Est. completion date: September 30, 2021

Study information

• Verified date: July 2022
• Source: Huawei Device Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 673
• Est. completion date: September 30, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arrhythmias, Cardiac

Intervention

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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Huawei Device Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Software failure rate		30seconds
Other	The incidence of adverse events and serious adverse events		30seconds
Primary	Sensitivity and specificity of atrial fibrillation identification		30seconds
Primary	Sensitivity and specificity of premature beat identification		30seconds
Primary	Sensitivity and specificity of sinus rhythm identification		30seconds
Secondary	Detection rate of ventricular premature beats and atrial premature beats		30seconds
Secondary	Total coincidence rate of measurement and identification		30seconds
Secondary	ECG waveform similarity		30seconds
Secondary	R wave amplitude consistency		30seconds
Secondary	Heart rate accuracy		30seconds
Secondary	Software usability		30seconds