Atrial FibrillationNCT06099249
Validation of ECG Measurement and Atrial Fibrillation Detection
An observational study of Atrial Fibrillation, run by ASUSTek Computer INC..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- ASUS ECG App
- Type of treatment
- Medical device
- How many people
- 602 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2023to 31 Dec 2024
- Phase
- Observational
- 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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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.
About this study
Official title: Validation of ECG Measurement and Atrial Fibrillation Detection Function of ASUS ECG App
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.
- Conditions
- Atrial Fibrillation
- Being tested
- ASUS ECG App
- Keywords
- Cardiovascular diseases, Heart Diseases, Arrhythmia, Cardiac
- Medical subject headings
- Atrial Fibrillation, Cardiovascular Diseases, Heart Diseases, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASUS ECG AppDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: ASUS ECG App |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and Specificity
Sensitivity and specificity of the ASUS ECG App in detecting AFib compared with physician-adjudicated 12-lead ECG will be calculated.
Measured: 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
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study start1 Nov 2023 (estimated)
- Primary completion30 Jun 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 602 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ASUSTek Computer INC.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Taipei Medical University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06099249
- Sponsor's protocol ID
- Validation of ECG Measurement
- Status last verified
- Oct 2023
- First submitted
- 16 Oct 2023
- Last updated
- 25 Oct 2023
- Results posted
- No
- Data monitoring committee
- 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 25 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of ECG Measurement and Atrial Fibrillation Detection Function of ASUS ECG App
- ClinicalTrials.gov ID
- NCT06099249
- Acronym / sponsor ID
- Validation of ECG Measurement
- Conditions
- Atrial Fibrillation
- Keywords
- Cardiovascular diseases, Heart Diseases, Arrhythmia, Cardiac
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 602 participants (estimated)
- Lead sponsor
- ASUSTek Computer INC.Industry (pharma, biotech, devices)
- Collaborators
- Taipei Medical University Hospital
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 25 Oct 2023 (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.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No_AFib_Group | – | Device: ASUS ECG AppSubjects enrolled into No_AFib_Group must have no known medical history of AFib and in normal sinus rhythm at the time of screening. |
| AFib_Group | – | Device: ASUS ECG AppSubjects enrolled into AFib_Group must have a known diagnosis of persistent or permanent AFib and be in AFib at the time of screening. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
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 |
|---|---|---|
| ASUS ECG AppThe 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. | Device | AFib_Group, No_AFib_Group |
Primary outcome
Sensitivity and Specificity
Time frame: One day
Sensitivity and specificity of the ASUS ECG App in detecting AFib compared with physician-adjudicated 12-lead ECG will be calculated.
1 secondary outcome
Equivalence of the ECG app waveform to Lead I from a 12-lead ECG
Time frame: One day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by ASUSTek Computer INC..
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 4 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 25 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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 (time frame: One day). 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 25 Oct 2023.