Arrhythmias, CardiacNCT05482503
Clinical Investigation to Evaluate the Effectiveness and Safety of ECG App
A study testing 12-Lead ECG(I-lead) in people with Arrhythmias, Cardiac, run by Huawei Device Co., Ltd at 2 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Arrhythmias, Cardiac
- What is being tested?
- 12-Lead ECG(I-lead)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 673 participants
- Where
- 2 sitesChina
- Study dates
- 2 Apr 2021to 30 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
2 sites in 1 country.
China2 sites
The First Medical Center of the Chinese PLA General Hospital & Medical School
Beijing
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou
About this study
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
- Being tested
- 12-Lead ECG(I-lead)
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
12-Lead ECG(I-lead)Device
All participants will simultaneously record 12-lead ECGs(I-lead)
| Study group | Role | What they receive |
|---|---|---|
| Atrial Fibrillation | Experimental | Not described Receives: Device: 12-Lead ECG(I-lead) |
| Premature beats | Experimental | Not described Receives: Device: 12-Lead ECG(I-lead) |
| Sinus Rhythm | Experimental | Not described Receives: Device: 12-Lead ECG(I-lead) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of atrial fibrillation identification
Measured: 30seconds
Sensitivity and specificity of premature beat identification
Measured: 30seconds
Sensitivity and specificity of sinus rhythm identification
Measured: 30seconds
Secondary outcomes (6)
Detection rate of ventricular premature beats and atrial premature beats
Measured: 30seconds
Total coincidence rate of measurement and identification
Measured: 30seconds
ECG waveform similarity
Measured: 30seconds
R wave amplitude consistency
Measured: 30seconds
Heart rate accuracy
Measured: 30seconds
Software usability
Measured: 30seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2022
- Study start2 Apr 2021
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arrhythmias, CardiacStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 673 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huawei Device Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Guo Yutao, doctor, Principal investigator, The First Medical Center of the Chinese PLA General Hospital & Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05482503
- Sponsor's protocol ID
- HWECG-001
- Status last verified
- Jul 2022
- First submitted
- 28 Jul 2022
- Last updated
- 2 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation to Evaluate the Effectiveness and Safety of ECG App
- ClinicalTrials.gov ID
- NCT05482503
- Acronym / sponsor ID
- HWECG-001
- Conditions
- Arrhythmias, Cardiac
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 673 participants (actual)
- Lead sponsor
- Huawei Device Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 2 Apr 2021 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 1 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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 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.
Key exclusion criteria (14 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 12-Lead ECG(I-lead)All participants will simultaneously record 12-lead ECGs(I-lead) | Device | Atrial Fibrillation, Premature beats, Sinus Rhythm |
Primary outcome
Sensitivity and specificity of atrial fibrillation identification
Time frame: 30seconds
Sensitivity and specificity of premature beat identification
Time frame: 30seconds
Sensitivity and specificity of sinus rhythm identification
Time frame: 30seconds
6 secondary outcomes
Detection rate of ventricular premature beats and atrial premature beats
Time frame: 30seconds
Total coincidence rate of measurement and identification
Time frame: 30seconds
ECG waveform similarity
Time frame: 30seconds
R wave amplitude consistency
Time frame: 30seconds
Heart rate accuracy
Time frame: 30seconds
Software usability
Time frame: 30seconds
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guo Yutao, doctor principal investigator
The First Medical Center of the Chinese PLA General Hospital & Medical School
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 12-Lead ECG(I-lead) in people with Arrhythmias, Cardiac, run by Huawei Device Co., Ltd at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of atrial fibrillation identification (time frame: 30seconds). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2022.