Clinical Investigation to Evaluate the Effectiveness and Safety of ECG App

NCT05482503 | Completed

• 1 other identifier: HWECG-001
• Study Type: interventional
• Target: 673
• Locations: 1 country
• Sites: 2

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.

Conditions

Arrhythmias, Cardiac

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• 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

Other Outcomes (2)

• Software failure rate

  30seconds

• The incidence of adverse events and serious adverse events

  30seconds

Study Arms (3)

Atrial Fibrillation

EXPERIMENTAL

Device: 12-Lead ECG(I-lead)

Premature beats

EXPERIMENTAL

Device: 12-Lead ECG(I-lead)

Sinus Rhythm

EXPERIMENTAL

Device: 12-Lead ECG(I-lead)

Interventions

12-Lead ECG(I-lead) DEVICE

All participants will simultaneously record 12-lead ECGs(I-lead)

Atrial Fibrillation; Premature beats; Sinus Rhythm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients over 18 years old, regardless of gender;
• 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:
• Patients with normal sinus rhythm;
• Patients with persistent or permanent paroxysmal atrial fibrillation or in the onset of paroxysmal atrial fibrillation;
• Patients with frequent premature beats (more than 5 per minute) or in the onset of premature beats;
• 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.

You may not qualify if:

• 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 escape rhythms;
• Patients with atrial tachycardia, atrial flutter, ventricular tachycardia, ventricular flutter, or ventricular fibrillation;
• Patients with a resting heart rate of slower than 50 beats/minute or faster than 110 beats/minute;
• Patients with atrial fibrillation complicated with premature beats;
• Patients who are critically ill, making it difficult to make an accurate assessment of the effectiveness and safety of the device;
• Patients who suffer from tremor diseases or chorea, making it difficult to complete the examination quietly;
• Patients with bullous diseases or large-area skin rashes that are not suitable for body 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 30 days that may affect this investigation; 15） Other conditions that the investigators consider inappropriate for participation in the investigation.

Sponsors & Collaborators

• Huawei Device Co., Ltd: lead

Study Sites (2)

The First Medical Center of the Chinese PLA General Hospital & Medical School

Beijing, China

Location

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, China

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Guo Yutao, doctor

  The First Medical Center of the Chinese PLA General Hospital & Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2022
• First Posted: August 1, 2022
• Study Start: April 2, 2021
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: August 2, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)