NCT07078071

Brief 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. The software is limited to alerting of atrial fibrillation and premature beat, and the results are only for clinical reference.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
199

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 18, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

July 12, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 22, 2025

Completed
Last Updated

July 22, 2025

Status Verified

July 1, 2025

Enrollment Period

4 months

First QC Date

July 12, 2025

Last Update Submit

July 12, 2025

Conditions

Arrhythmia, Heart

Outcome Measures

Primary Outcomes (2)

  • Sensitivity and specificity of atrial fibrillation identification in a single measurement

    45seconds

  • Sensitivity and specificity of premature beat identification in a single measurement

    45seconds

Secondary Outcomes (3)

  • Accuracy in identifying the non-arrhythmia in a single measurement

    45seconds

  • Total identification compliance rate in a single measurement

    45seconds

  • Software usability

    45seconds

Study Arms (3)

Atrial Fibrillation

EXPERIMENTAL
Device: ECG

Premature beats

EXPERIMENTAL
Device: ECG

No evidence of atrial fibrillation/premature beats

EXPERIMENTAL
Device: ECG

Interventions

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.

Atrial FibrillationNo evidence of atrial fibrillation/premature beatsPremature beats

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (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 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 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;
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhujiang Hospital of Southern Medical University

Guangzhou, China

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac

Interventions

Electrocardiography

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisElectrodiagnosis

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 12, 2025

First Posted

July 22, 2025

Study Start

October 18, 2022

Primary Completion

March 1, 2023

Study Completion

March 1, 2023

Last Updated

July 22, 2025

Record last verified: 2025-07

Locations

CN(1)