Atrial FibrillationNCT05830578
Clinical Validation of the Electrocardiogram Measurement
An observational study of Atrial Fibrillation, run by Taipei Medical University Hospital.
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 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- ASUS Blood Pressure Monitor/Oximeter/ECG Monitor
- Type of treatment
- Medical device
- How many people
- 602 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2023to 30 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 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study will include two cohorts of subjects: 1. Cohort 1 will include subjects with no known history of AFib and are in normal sinusn rhythm at time of screening. 2. Cohort 2 will include subjects with known persistent or permanent or chronic AFib who are in AFib at the time of screening. The study will enroll equal subjects with and without a known diagnoiss of AFib into two separate cohorts. A total of 602 subjects will be recruited (301 for SR cohort and 301 for AFib cohort). 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 ≥65 years, and a minimum of 10% of subjects in both cohorts in the age category of <55 years. 2. At least 40% of subjects in Cohort 1 will be female. At least 20% of subjects in Cohort 2 will be female.
Who may be able to join
- Willing and able to participate in the study procedures as described in the consent form
- Individuals who are 22 years of age and older at time of screening
- Able to communicate effectively with and follow instructions from the study staff
- Subjects enrolled into Cohort 1 must have no known medical history of AFib and in normal sinus rhythm at the time of screening.
- Subjects enrolled into Cohort 2 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.
- Vital signs measurement, medical history, or physical exam finding that makes the subject inappropriate for participation according to the Investigator.
Show all 11Show fewer
- 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: Clinical Validation of the Electrocardiogram Measurement and Atrial Fibrillation Detection Function of a Wearable Smartwatch
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 Blood Pressure Monitor/Oximeter/ECG Monitor. 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 22. 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 Blood Pressure Monitor/Oximeter/ECG Monitor
- Keywords
- Electrocardiogram, Atrial Fibrillation, Validation, Software as Medical Device (SaMD)
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASUS Blood Pressure Monitor/Oximeter/ECG MonitorDevice
The ASUS Blood Pressure Monitor/Oximeter/ECG Monitor analyzes data collected by the integrated electrical sensors on a ASUS Vivowatch to generate an ECG waveform similar to a Lead I, calculate average heart rate, and provide a rhythm classification to the user for a given 30 second session. When a user opens the ECG App while wearing the ASUS VivoWatch on one wrist and places the finger of the opposite hand on the digital crown, they are completing the circuit across the heart which begins a recording session.
Once the recording session is complete, the ECG App performs signal processing, feature extraction and rhythm classification to generate a session result.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Subjects enrolled into Cohort 1 must have no known medical history of AFib and in normal sinus rhythm at the time of screening. Receives: Device: ASUS Blood Pressure Monitor/Oximeter/ECG Monitor | |
| Cohort 2 | Subjects enrolled into Cohort 2 must have a known diagnosis of persistent or permanent AFib and be in AFib at the time of screening. Receives: Device: ASUS Blood Pressure Monitor/Oximeter/ECG Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of the ECG App algorithm
Sensitivity and specificity of the ECG App algorithm in detecting AFib compared with physician-adjudicated 12-lead ECG will be calculated.
Measured: One day visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2023
- Study start1 Dec 2023 (estimated)
- Primary completion30 Jun 2024 (estimated)
- Study completion30 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
- Taipei Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05830578
- Sponsor's protocol ID
- ECG and AF Validation
- Status last verified
- Apr 2023
- First submitted
- 14 Apr 2023
- Last updated
- 24 Nov 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 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Validation of the Electrocardiogram Measurement and Atrial Fibrillation Detection Function of a Wearable Smartwatch
- ClinicalTrials.gov ID
- NCT05830578
- Acronym / sponsor ID
- ECG and AF Validation
- Conditions
- Atrial Fibrillation
- Keywords
- Electrocardiogram, Atrial Fibrillation, Validation, Software as Medical Device (SaMD)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 602 participants (estimated)
- Lead sponsor
- Taipei Medical University HospitalUniversity, hospital or other
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 26 Apr 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 Blood Pressure Monitor/Oximeter/ECG Monitor. 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 22. 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 |
|---|---|---|
| Cohort 1 | – | Device: ASUS Blood Pressure Monitor/Oximeter/ECG MonitorSubjects enrolled into Cohort 1 must have no known medical history of AFib and in normal sinus rhythm at the time of screening. |
| Cohort 2 | – | Device: ASUS Blood Pressure Monitor/Oximeter/ECG MonitorSubjects enrolled into Cohort 2 must have a known diagnosis of persistent or permanent AFib and be in AFib at the time of screening. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study will include two cohorts of subjects: 1. Cohort 1 will include subjects with no known history of AFib and are in normal sinusn rhythm at time of screening. 2. Cohort 2 will include subjects with known persistent or permanent or chronic AFib who are in AFib at the time of screening. The study will enroll equal subjects with and without a known diagnoiss of AFib into two separate cohorts. A total of 602 subjects will be recruited (301 for SR cohort and 301 for AFib cohort). 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 ≥65 years, and a minimum of 10% of subjects in both cohorts in the age category of <55 years. 2. At least 40% of subjects in Cohort 1 will be female. At least 20% of subjects in Cohort 2 will be female.
Key inclusion criteria (5 listed)
- Willing and able to participate in the study procedures as described in the consent form
- Individuals who are 22 years of age and older at time of screening
- Able to communicate effectively with and follow instructions from the study staff
- Subjects enrolled into Cohort 1 must have no known medical history of AFib and in normal sinus rhythm at the time of screening.
- Subjects enrolled into Cohort 2 must have a known diagnosis of persistent or permanent AFib and be in AFib at the time of screening.
Key exclusion criteria (11 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.
- 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.
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 Blood Pressure Monitor/Oximeter/ECG MonitorThe ASUS Blood Pressure Monitor/Oximeter/ECG Monitor analyzes data collected by the integrated electrical sensors on a ASUS Vivowatch to generate an ECG waveform similar to a Lead I, calculate average heart rate, and provide a rhythm classification to the user for a given 30 second session. When a user opens the ECG App while wearing the ASUS VivoWatch on one wrist and places the finger of the opposite hand on the digital crown, they are completing the circuit across the heart which begins a recording session. Once the recording session is complete, the ECG App performs signal processing, feature extraction and rhythm classification to generate a session result. | Device | Cohort 1, Cohort 2 |
Primary outcome
Sensitivity and specificity of the ECG App algorithm
Time frame: One day visit
Sensitivity and specificity of the ECG App algorithm in detecting AFib compared with physician-adjudicated 12-lead ECG will be calculated.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 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 Taipei Medical University Hospital.
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 5 inclusion and 11 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 24 Nov 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 of the ECG App algorithm (time frame: One day visit). 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 24 Nov 2023.