Back to resultsClinical Investigation to Evaluate the Effectiveness and Safety of ECG App
Primary Purpose
Arrhythmias, Cardiac
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
12-Lead ECG(I-lead)
Sponsored by
About this trial
This is an interventional diagnostic trial for Arrhythmias, Cardiac
Eligibility Criteria
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.
Sites / Locations
- The First Medical Center of the Chinese PLA General Hospital & Medical School
- The First Affiliated Hospital of Sun Yat-sen University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Atrial Fibrillation
Premature beats
Sinus Rhythm
Arm Description
Outcomes
Primary Outcome Measures
Sensitivity and specificity of atrial fibrillation identification
Sensitivity and specificity of premature beat identification
Sensitivity and specificity of sinus rhythm identification
Secondary Outcome Measures
Detection rate of ventricular premature beats and atrial premature beats
Total coincidence rate of measurement and identification
ECG waveform similarity
R wave amplitude consistency
Heart rate accuracy
Software usability
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05482503
Brief Title
Clinical Investigation to Evaluate the Effectiveness and Safety of ECG App
Official Title
Clinical Investigation to Evaluate the Effectiveness and Safety of ECG App
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
April 2, 2021 (Actual)
Primary Completion Date
September 30, 2021 (Actual)
Study Completion Date
September 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Huawei Device Co., Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arrhythmias, Cardiac
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
673 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Atrial Fibrillation
Arm Type
Experimental
Arm Title
Premature beats
Arm Type
Experimental
Arm Title
Sinus Rhythm
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
12-Lead ECG(I-lead)
Intervention Description
All participants will simultaneously record 12-lead ECGs(I-lead)
Primary Outcome Measure Information:
Title
Sensitivity and specificity of atrial fibrillation identification
Time Frame
30seconds
Title
Sensitivity and specificity of premature beat identification
Time Frame
30seconds
Title
Sensitivity and specificity of sinus rhythm identification
Time Frame
30seconds
Secondary Outcome Measure Information:
Title
Detection rate of ventricular premature beats and atrial premature beats
Time Frame
30seconds
Title
Total coincidence rate of measurement and identification
Time Frame
30seconds
Title
ECG waveform similarity
Time Frame
30seconds
Title
R wave amplitude consistency
Time Frame
30seconds
Title
Heart rate accuracy
Time Frame
30seconds
Title
Software usability
Time Frame
30seconds
Other Pre-specified Outcome Measures:
Title
Software failure rate
Time Frame
30seconds
Title
The incidence of adverse events and serious adverse events
Time Frame
30seconds
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guo Yutao, doctor
Organizational Affiliation
The First Medical Center of the Chinese PLA General Hospital & Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Medical Center of the Chinese PLA General Hospital & Medical School
City
Beijing
Country
China
Facility Name
The First Affiliated Hospital of Sun Yat-sen University
City
Guangzhou
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Investigation to Evaluate the Effectiveness and Safety of ECG App
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