Arrhythmia, HeartNCT07078071

Clinical Trial for Evaluating the Effectiveness and Safety of the Pulse Wave-based Atrial Fibrillation and Premature Beat Alert Software

A study testing ECG in people with Arrhythmia, Heart, run by Huawei Device Co., Ltd at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study aims to validate the efficacy and safety of the Pulse Wave-based Atrial Fibrillation and Premature Beat Alert Software (Huawei Device Co., Ltd.). This software can provide alerts, store and display PPG data transmitted from smartwatches or fitness trackers. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Arrhythmia, Heart
What is being tested?: ECG
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 199 participants
Where: 1 siteChina
Study dates: 18 Oct 2022to 1 Mar 2023
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 volunteer to participate and have signed an informed consent form.

Who cannot join

Patients using cardiac pacemakers or implantable cardioverter defibrillators (ICD);
Patients with non-respiratory sinus arrhythmia, sinus arrest or sick sinus syndrome according to the ECG results during the screening period;
Patients with interpolated premature beats, junctional premature beats, or escape rhythms according to the ECG results during the screening period;
Patients with atrial flutter, ventricular flutter, or ventricular fibrillation according to the ECG results during the screening period;
Patients with atrial fibrillation or premature beats who have a resting heart rate of slower than 50 beats/minute or faster than 110 beats/minute according to the ECG results during the screening period;
Patients who are critically ill, making it difficult to make an accurate assessment of the effectiveness and safety of the device;

Show all 14Show fewer

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 tattoos on their wrist skin that is to be measured;
Patients with poor compliance who are unable to cooperate to complete this investigation on their own;
Patients who have participated in other clinical investigations within the past 30 days that may affect this investigation;
Other conditions that the investigators consider inappropriate for participation in the investigation.

Trial locations and contacts

1 site in 1 country.

China1 site

Zhujiang Hospital of Southern Medical University
Guangzhou

Other trials in China

About this study

Conditions: Arrhythmia, Heart
Being tested: ECG
Medical subject headings: Arrhythmias, Cardiac

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ECGDevice
Each participant undergoes testing with both the investigation device and the control device simultaneously. The results of the investigation device, which are obtained through pulse wave data analysis at the wrist, are compared to the investigator's interpretation of the ECG.

Study groups in NCT07078071
Study group	Role	What they receive
Atrial Fibrillation	Experimental	Not described Receives: Device: ECG
Premature beats	Experimental	Not described Receives: Device: ECG
No evidence of atrial fibrillation/premature beats	Experimental	Not described Receives: Device: ECG

What is being measured

The primary outcome is the main question the study is designed to answer.

Sensitivity and specificity of atrial fibrillation identification in a single measurement
Measured: 45seconds
Sensitivity and specificity of premature beat identification in a single measurement
Measured: 45seconds

Secondary outcomes (3)

Accuracy in identifying the non-arrhythmia in a single measurement
Measured: 45seconds
Total identification compliance rate in a single measurement
Measured: 45seconds
Software usability
Measured: 45seconds

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Oct 20221 Mar 2023

First posted22 Jul 2025
Study start18 Oct 2022
Primary completion1 Mar 2023
Study completion1 Mar 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Arrhythmia, HeartStudies 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: 199 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07078071
Sponsor's protocol ID: HW-XLSCRJ-001
Status last verified: Jul 2025
First submitted: 12 Jul 2025
Last updated: 22 Jul 2025
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
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nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
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Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Not yet recruiting
Smartphone Camera Measurement of Breathing-Related Heart Rate Variability Compared With ECG in Healthy Adults
Respiratory Sinus Arrhythmia, Heart Rate Variability
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation

All Arrhythmia, Heart trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Trial for Evaluating the Effectiveness and Safety of the Pulse Wave-based Atrial Fibrillation and Premature Beat Alert Software
ClinicalTrials.gov ID: NCT07078071
Acronym / sponsor ID: HW-XLSCRJ-001
Conditions: Arrhythmia, Heart
Study type: Interventional
Recruitment status: Completed
Enrolment: 199 participants (actual)
Lead sponsor: Huawei Device Co., LtdIndustry (pharma, biotech, devices)
Study start: 18 Oct 2022 (actual)
Primary completion: 1 Mar 2023 (actual)
Study completion: 1 Mar 2023 (actual)
First posted: 22 Jul 2025 (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.

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: ECG
Premature beats	Experimental	Device: ECG
No evidence of atrial fibrillation/premature beats	Experimental	Device: ECG

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 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 non-respiratory sinus arrhythmia, sinus arrest or sick sinus syndrome according to the ECG results during the screening period;
Patients with interpolated premature beats, junctional premature beats, or escape rhythms according to the ECG results during the screening period;
Patients with atrial flutter, ventricular flutter, or ventricular fibrillation according to the ECG results during the screening period;
Patients with atrial fibrillation or premature beats who have a resting heart rate of slower than 50 beats/minute or faster than 110 beats/minute according to the ECG results during the screening period;

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
ECGEach participant undergoes testing with both the investigation device and the control device simultaneously. The results of the investigation device, which are obtained through pulse wave data analysis at the wrist, are compared to the investigator's interpretation of the ECG.	Device	Atrial Fibrillation, No evidence of atrial fibrillation/premature beats, Premature beats

Primary outcome

Sensitivity and specificity of atrial fibrillation identification in a single measurement
Time frame: 45seconds
Sensitivity and specificity of premature beat identification in a single measurement
Time frame: 45seconds

3 secondary outcomes

Accuracy in identifying the non-arrhythmia in a single measurement
Time frame: 45seconds
Total identification compliance rate in a single measurement
Time frame: 45seconds
Software usability
Time frame: 45seconds

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 22 Jul 2025.

Related trials for Arrhythmia, Heart

RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Not yet recruiting
Smartphone Camera Measurement of Breathing-Related Heart Rate Variability Compared With ECG in Healthy Adults
Respiratory Sinus Arrhythmia, Heart Rate Variability
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation

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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing ECG in people with Arrhythmia, Heart, run by Huawei Device Co., Ltd at 1 site 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 22 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 in a single measurement (time frame: 45seconds). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07078071.

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 22 Jul 2025.