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Not yet recruitingNCT06099249Updated Oct 25, 2023

Validation of ECG Measurement and Atrial Fibrillation Detection

An observational study in Atrial Fibrillation, sponsored by ASUSTek Computer INC.. Not yet recruiting. Open to participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-25.

Sponsored by ASUSTek Computer INC. · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2024, 2 years 3 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
602
Ages
18 Years to 99 Years
Sex
All
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Study summary

Atrial fibrillation (AFib) is a common type of cardiac arrhythmia in clinical practice, affecting millions of people worldwide. Early detection and treatment of atrial fibrillation are crucial in preventing serious complications such as stroke and heart failure. In recent years, with the flourishing development of wearable devices and mobile technology, electrocardiogram (ECG) measurement applications embedded in smartwatches have gradually become a non-invasive and convenient method for heart rate monitoring. However, the accuracy of these devices has not yet been fully determined. This study aims to verify the ECG measurement and atrial fibrillation detection function of the ASUS ECG App. The accuracy of the ECG application in detecting atrial fibrillation and measuring ECG will be evaluated by comparison with standard 12-lead ECGs.

Read the detailed description

This study plans to recruit 602 adults over the age of 18. All participants will undergo heart rate measurements using both the smartwatch ECG application and the 12-lead ECG. The heart rate measurement using the ECG application will be operated by the participants themselves under the guidance of the testing personnel. The 12-lead ECG will be operated by trained medical professionals. The results of the heart rate measurement from both devices will be recorded synchronously, and the consistency of heart rate interpretation and ECG waveforms between the smartwatch ECG application and the 12-lead ECG measurement will be compared to verify the accuracy of the ECG application.

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Conditions studied

  • Atrial Fibrillation

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Keywords

  • Cardiovascular diseases
  • Heart Diseases
  • Arrhythmia
  • Cardiac
03

In context

Atrial Fibrillation

3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.

This study's planned enrollment of 602 is above the median of 300 across 1,363 observational studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

ASUSTek Computer INC. is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

The study will include two cohorts of subjects:

  1. No_AFib_Group will include subjects with no known history of AFib and are in normal sinus rhythm at time of screening.
  2. AFib_Group will include subjects with known persistent or permanent or chronic AFib who are in AFib at the time ofscreening.

The following age and gender enrollment targets will be adhered to during subject recruitment:

  1. A minimum of 20% of subjects in both cohorts will be enrolled in each of the age categories of 55 to 64, and ≥65years, and a minimum of 10% of subjects in both cohorts in the age category of \<55 years.
  2. At least 40% of subjects in No_AFib_Group will be female. At least 20% of subjects in AFib_Group will be female.

Inclusion criteria

  • Willing and able to participate in the study procedures as described in the consent form
  • Able to communicate effectively with and follow instructions from the study staff
  • Subjects enrolled into No_AFib_Group must have no known medical history of AFib and in normal sinus rhythm at the time of screening.
  • Subjects enrolled into AFib_Group must have a known diagnosis of persistent or permanent AFib and be in AFib at the time of screening.

Exclusion criteria

Exclusion Criteria:

  • Physical disability that precludes safe and adequate testing.
  • Mental impairment as determined by the Investigator.
  • Pregnant women at the time of the screening visit.
  • Subjects with any Medical History, Physical exam, vital sign or any other study procedure finding/assessment that in the opinion of the investigator could compromise subject safety during study participation or interfere with the study integrity and/or the accurate assessment of the study objectives. This includes patients with known untreated medical conditions that are considered clinically significant by the Investigator, such as but not limited to significant anemia, important electrolyte imbalance and untreated or uncontrolled thyroid disease.
  • Physical exam limitations include but not limited to open wound(s) on the wrist and forearm where the subject will be wearing the watch.
  • Any history of wrist surgery with scarring in the area of the sensor location on the wrist where the subject will be wearing the watch.
  • Vital signs measurement, medical history, or physical exam finding that makes the subject inappropriate for participation according to the Investigator.
  • Tattoos or moles in the area of the sensor location on the wrist where the subject will be wearing the watch.
  • Skin conditions on either wrist that would preclude subject from wearing watch on either wrist. Severe symptomatic(or active) overly dry/injured skin, skin disorders, or allergic skin reactions such as eczema, rosacea, impetigo,dermatomyositis or allergic contact dermatitis on wrist and locations where the electrodes will be placed (e.g.

chest,forearms, stomach), as determined by the investigator.

  • Known allergy or significant sensitivity to medical adhesives, isopropyl alcohol, or ECG patch.
  • Clinically significant hand tremors as judged by the Investigator.
  • Subjects with implanted cardiac devices such as a Pacemaker or an automated Implantable Cardioverter-Defibrillator.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
602 participants (estimated)
Patient registry
No

Groups and cohorts

  • No_AFib_Group

    Subjects enrolled into No_AFib_Group must have no known medical history of AFib and in normal sinus rhythm at the time of screening.

    Device: ASUS ECG App

  • AFib_Group

    Subjects enrolled into AFib_Group must have a known diagnosis of persistent or permanent AFib and be in AFib at the time of screening.

    Device: ASUS ECG App

Interventions

  • DeviceASUS ECG App

    The procedure will commence with instructing the participants to become acquainted with the ASUS ECG App. Following this introduction, participants will be asked to sit quietly for a 5-minute resting period before undergoing a 12-lead ECG recording, which will last for approximately 30 seconds. The participant will be guided to simultaneously record a separate single-lead ECG using the ASUS ECG App. Both data streams will be synced together by the Study Staff. Each participant will undergo a total of three trials involving the simultaneous recording of a 12-lead ECG and a single-lead ECG using the ASUS ECG App.

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What researchers measure

Primary outcomes

  1. Sensitivity and Specificity

    Sensitivity and specificity of the ASUS ECG App in detecting AFib compared with physician-adjudicated 12-lead ECG will be calculated.

    Time frame: One day

Secondary outcomes

  1. Equivalence of the ECG app waveform to Lead I from a 12-lead ECG

    Equivalence of the ECG app waveform to Lead I from a 12-lead ECG as measured by acceptable morphology of PQRST complexes and R-Wave amplitude agreement

    Time frame: One day

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 25, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06099249
Lead sponsor
ASUSTek Computer INC.
Collaborators
Taipei Medical University Hospital
Responsible party
Sponsor
First posted
Oct 25, 2023
Start date
Nov 1, 2023 (estimated)
Primary completion
Jun 30, 2024 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
Oct 25, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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