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Completed

NCT Number: NCT05482503

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

12-Lead ECG(I-lead)

Device

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

Primary outcomes

  1. Sensitivity and specificity of atrial fibrillation identification

    Time frame: 30seconds

  2. Sensitivity and specificity of premature beat identification

    Time frame: 30seconds

  3. Sensitivity and specificity of sinus rhythm identification

    Time frame: 30seconds

Secondary outcomes

  1. Detection rate of ventricular premature beats and atrial premature beats

    Time frame: 30seconds

  2. Total coincidence rate of measurement and identification

    Time frame: 30seconds

  3. ECG waveform similarity

    Time frame: 30seconds

  4. R wave amplitude consistency

    Time frame: 30seconds

  5. Heart rate accuracy

    Time frame: 30seconds

  6. Software usability

    Time frame: 30seconds

Other outcomes

  1. Software failure rate

    Time frame: 30seconds

  2. The incidence of adverse events and serious adverse events

    Time frame: 30seconds

Sponsors and collaborators

Lead sponsor

Huawei Device Co., Ltd

Industry

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Aug 1, 2022
Registry last updated
Aug 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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