Atrial FibrillationNCT06907264
Wearable ECG for AF Screening and Stroke Risk Assessment
An observational study of Atrial Fibrillation and Stroke, run by Beijing Tsinghua Chang Gung Hospital at 2 sites in China.
Trial summary
This study aims to evaluate the application of wearable ECG garments in atrial fibrillation (AF) screening and stroke risk assessment. Using a prospective, multicenter, observational design, the study will recruit high-risk stroke patients aged 40 and above to undergo 24-hour continuous ECG monitoring with wearable… Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation, Stroke
- What is being tested?
- Wearable ECG Garment for Continuous Atrial Fibrillation Screening and Stroke Risk Assessment
- Type of treatment
- Medical device
- How many people
- 243 participants
- Where
- 2 sitesChina
- Study dates
- 1 Apr 2025to 31 Dec 2027
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population consists of individuals aged 40 years and above who are identified as high-risk for stroke based on the "8+2" stroke risk score. This population includes individuals with elevated stroke risk factors such as hypertension, diabetes, smoking history, and family history of stroke. Participants must be able to operate the wearable ECG garment independently or with assistance from family members and must provide informed consent to participate in the study. The study aims to enroll 243 participants to ensure sufficient statistical power for evaluating the accuracy of the wearable ECG garment in detecting atrial fibrillation (AF) and assessing stroke risk.
Who may be able to join
- Age ≥ 40 years.
- High-risk stroke population identified by the "8+2" risk score in stroke screening.
- Ability to operate the device independently or with assistance from family members.
- Willingness to participate in the study and provide signed informed consent.
Who cannot join
- Patients with severe diseases that limit device wear (e.g., advanced malignant tumors, severe infections, Class IV heart failure) or those receiving hospice care.
- Patients unable to operate the device or understand the study procedures due to cognitive impairment, mental illness, or language communication barriers.
- Patients who may experience severe discomfort or allergic reactions from wearing the device.
- Patients already using implanted cardiac monitoring devices.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, 102218
Yating Wu, MD., +86 56119526, wuyating926@163.com
Pinggu District Hospital
Beijing, 101200
Yifei Chen, MD., 13264334052, 13264334052@wo.cn
About this study
Official title: Application of Wearable ECG Garments in Atrial Fibrillation Screening and Stroke Risk Assessment
This study aims to evaluate the application of wearable ECG garments in atrial fibrillation (AF) screening and stroke risk assessment. Using a prospective, multicenter, observational design, the study will recruit high-risk stroke patients aged 40 and above to undergo 24-hour continuous ECG monitoring with wearable ECG garments. The study will assess the detection rate of AF and explore the correlation between heart rate variability (HRV) parameters and stroke risk. Additionally, the study will analyze the association between P-wave indices and AF, and evaluate the acceptability of the device among patients and healthcare providers. The primary goal is to validate the accuracy of wearable ECG garments in AF detection and explore their predictive value for stroke risk in high-risk populations.
Read the detailed description
This study is a prospective, multicenter, observational study designed to evaluate the application of wearable ECG garments in atrial fibrillation (AF) screening and stroke risk assessment. The study will be conducted at two centers: the Tsinghua Community under the jurisdiction of Tsinghua University Hospital and the Pinggu District under the jurisdiction of Pinggu District Hospital. The study design includes the following key components:
Study Population:
The study population consists of individuals aged 40 and above who are at high risk of stroke, as determined by the "8+2" stroke risk score.
Participants must be able to operate the wearable ECG garment independently or with the assistance of family members and must provide informed consent.
Sample Size:
Based on preliminary data, the AF detection rate in the local community population aged 40 and above is 3.68%. Using a two-sided test with a significance level of α=0.05 and an allowable error of d=2.5%, the calculated sample size is 218. Considering a 10% dropout rate, the final sample size is 243.
Intervention Methods:
Baseline Assessment: Collect demographic information (e.g., age, gender, height, weight) and clinical information (e.g., hypertension, diabetes, smoking history) from participants.
Device Wear and Monitoring: Participants will wear the wearable ECG garment for 24-hour continuous ECG monitoring. The device will record ECG signals in real time, including heart rate, rhythm, HRV parameters (e.g., SDNN, RMSSD, LF/HF), and P-wave indices.
Data Processing: Daily review of uploaded ECG data to analyze AF events. For participants with suspected AF, further evaluation with a 12-lead ECG or 24-hour Holter monitoring is recommended. HRV parameters will be extracted and analyzed for their correlation with stroke risk.
Acceptability Assessment: The acceptability of the device among participants and healthcare providers will be assessed through quantitative and qualitative methods. Quantitative data include device wear time and interruption rates, while qualitative data are collected through questionnaires and semi-structured interviews.
Outcome Measures:
Primary Outcomes: AF detection rate of the wearable ECG garment; correlation between HRV parameters (e.g., SDNN, RMSSD, LF/HF) and stroke risk.
Secondary Outcomes: Correlation between P-wave indices and AF; acceptability of the device among patients and healthcare providers; incidence of stroke and composite vascular events (e.g., myocardial infarction, heart failure, vascular death) during long-term follow-up.
Follow-up Plan:
Participants will be followed up at 6 and 12 months after enrollment to record the occurrence of stroke, AF, and other cardiovascular events.
Statistical Analysis:
Data will be analyzed using SPSS 25.0. Normally distributed continuous variables will be expressed as mean ± standard deviation, while non-normally distributed variables will be expressed as median and interquartile range. Group comparisons will be made using t-tests or chi-square tests, and correlation analyses will be performed using Pearson or Spearman rank correlation. Predictive factors for AF events and other outcomes will be determined through multivariate competing risk analysis.
Data Management:
All data will be entered into an electronic case report form (eCRF) and uploaded to a cloud database in real time. The research team will regularly review the completeness and accuracy of the data to ensure data quality.
Safety Assessment:
The safety of device use will be assessed, including the comfort of long-term wear and the incidence of adverse reactions (e.g., skin allergies or local irritation). The impact of false positives or false negatives on medical decision-making will also be evaluated.
- Conditions
- Atrial Fibrillation, Stroke
- Being tested
- Wearable ECG Garment for Continuous Atrial Fibrillation Screening and Stroke Risk Assessment
- Keywords
- Wearable ECG garment, Atrial fibrillation, Stroke, Heart rate variability, Observational study, High-risk stroke population
- Medical subject headings
- Atrial Fibrillation, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearable ECG Garment for Continuous Atrial Fibrillation Screening and Stroke Risk AssessmentDevice
This intervention utilizes a wearable ECG garment, a non-invasive, textile-based device for continuous 24-hour ECG monitoring. The garment features embedded electrodes to capture heart rate, rhythm, HRV parameters (e.g., SDNN, RMSSD, LF/HF), and P-wave indices (e.g., P-wave duration, PtfV1), enabling comprehensive assessment of atrial fibrillation (AF) and stroke risk. The device is lightweight, comfortable, and supports wireless data transmission to the cloud for real-time analysis. The study incorporates machine learning algorithms to identify AF patterns and explore stroke risk predictors, targeting individuals aged 40+ at high stroke risk. It also evaluates device acceptability and usability, aiming to improve AF detection rates, enable early intervention, and reduce stroke risk.
| Study group | Role | What they receive |
|---|---|---|
| High-Risk Stroke Cohort with Wearable ECG Garment | This cohort consists of individuals aged 40 and above who are at high risk of stroke, as determined by the "8+2" stroke risk score. Participants will wear a wearable ECG garment for 24-hour continuous ECG monitoring to detect atrial fibrillation (AF) and assess stroke risk. The device will record heart rate, rhythm, HRV parameters (e.g., SDNN, RMSSD, LF/HF), and P-wave indices. The study aims to evaluate the accuracy of the wearable ECG garment in AF detection, explore the correlation between HRV parameters and stroke risk, and assess the acceptability of the device among patients and healthcare providers. Participants will undergo follow-up at 6 and 12 months to monitor the occurrence of stroke, AF, and other cardiovascular events. Receives: Device: Wearable ECG Garment for Continuous Atrial Fibrillation Screening and Stroke Risk Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Atrial Fibrillation Detection Rate in Stroke High-Risk Populations Using Wearable ECG Garment
1.Atrial Fibrillation (AF) Detection Rate: The proportion of AF cases identified by the wearable ECG garment in the high-risk stroke population during 24-hour continuous monitoring.
Measured: Baseline to 12 months: Continuous 24-hour ECG monitoring at baseline, with follow-up at 6 and 12 months to assess AF.
Correlation Between HRV Parameters and Stroke Risk in High-Risk Populations Using Wearable ECG Garment
Correlation Between HRV Parameters and Stroke Risk: Analysis of key HRV parameters (e.g., SDNN, RMSSD, LF/HF) to assess their association with AF and stroke risk in high-risk individuals.
Measured: Baseline to 12 months: Continuous 24-hour ECG monitoring at baseline, with follow-up at 6 and 12 months to assess stroke.
Secondary outcomes (3)
Development of an AF Risk Prediction Model Using P-Wave Indices in High-Risk Stroke Populations
Development and validation of an AF risk prediction model incorporating P-wave indices (e.g., P-wave duration, PtfV1) to assess its predictive ability in high-risk stroke populations.
Measured: P-wave indices collected during 24-hour ECG monitoring at baseline, with model validation using follow-up data at 6 and 12 months.
Patient and Healthcare Provider Acceptability of Wearable ECG Garment
Evaluation of patient and healthcare provider satisfaction, usability, and comfort with the wearable ECG garment through questionnaires and semi-structured interviews.
Measured: Baseline to 12 months: Acceptability assessed at baseline (after initial use) and during follow-up visits at 6 and 12 months.
Incidence of Stroke, AF, and Composite Vascular Events During Long-Term Follow-Up
Occurrence of stroke、AF and Composite vascular events, including myocardial infarction, heart failure, and vascular death during the 12-month follow-up period.
Measured: Baseline to 12 months: Continuous 24-hour ECG monitoring at baseline, with follow-up assessments at 6 and 12 months to track clinical outcomes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2025
- Study start1 Apr 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (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.
- More trials run by Beijing Tsinghua Chang Gung HospitalThe sponsor's other registered studies.
- 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
- 243 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Beijing Tsinghua Chang Gung Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Pinggu District Hospital
- Responsible party
- Sponsor
- Investigators
- Jian Wu, MD., Study chair, BeijingTsinghua Changgung Hospital, School of Clinical Medicine,Tsinghua Medicine, Tsinghua UniversityYating Wu, MD., Principal investigator, BeijingTsinghua Changgung Hospital, School of Clinical Medicine,Tsinghua Medicine, Tsinghua UniversityYifei Chen, MD., Principal investigator, Pinggu District Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06907264
- Sponsor's protocol ID
- 2023YFC2506600
- Status last verified
- Feb 2025
- First submitted
- 26 Mar 2025
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared to protect participant privacy and confidentiality. The data contain sensitive personal health information, and sharing it publicly could compromise participant anonymity. Additionally, the informed consent process did not include provisions for public data sharing, and releasing the data could violate participant consent agreements. The data are solely intended for use by the research team to achieve the study objectives."
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Wearable ECG Garments in Atrial Fibrillation Screening and Stroke Risk Assessment
- ClinicalTrials.gov ID
- NCT06907264
- Acronym / sponsor ID
- 2023YFC2506600
- Conditions
- Atrial Fibrillation, Stroke
- Keywords
- Wearable ECG garment, Atrial fibrillation, Stroke, Heart rate variability, Observational study, High-risk stroke population
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 243 participants (estimated)
- Lead sponsor
- Beijing Tsinghua Chang Gung HospitalUniversity, hospital or other
- Collaborators
- Beijing Pinggu District Hospital
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 2 Apr 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.
This study aims to evaluate the application of wearable ECG garments in atrial fibrillation (AF) screening and stroke risk assessment. Using a prospective, multicenter, observational design, the study will recruit high-risk stroke patients aged 40 and above to undergo 24-hour continuous ECG monitoring with wearable ECG garments. The study will assess the detection rate of AF and explore the correlation between heart rate variability (HRV) parameters and stroke risk. Additionally, the study will analyze the association between P-wave indices and AF, and evaluate the acceptability of the device among patients and healthcare providers. The primary goal is to validate the accuracy of wearable ECG garments in AF detection and explore their predictive value for stroke risk in high-risk populations.
Detailed description
This study is a prospective, multicenter, observational study designed to evaluate the application of wearable ECG garments in atrial fibrillation (AF) screening and stroke risk assessment. The study will be conducted at two centers: the Tsinghua Community under the jurisdiction of Tsinghua University Hospital and the Pinggu District under the jurisdiction of Pinggu District Hospital. The study design includes the following key components:
Study Population:
The study population consists of individuals aged 40 and above who are at high risk of stroke, as determined by the "8+2" stroke risk score.
Participants must be able to operate the wearable ECG garment independently or with the assistance of family members and must provide informed consent.
Sample Size:
Based on preliminary data, the AF detection rate in the local community population aged 40 and above is 3.68%. Using a two-sided test with a significance level of α=0.05 and an allowable error of d=2.5%, the calculated sample size is 218. Considering a 10% dropout rate, the final sample size is 243.
Intervention Methods:
Baseline Assessment: Collect demographic information (e.g., age, gender, height, weight) and clinical information (e.g., hypertension, diabetes, smoking history) from participants.
Device Wear and Monitoring: Participants will wear the wearable ECG garment for 24-hour continuous ECG monitoring. The device will record ECG signals in real time, including heart rate, rhythm, HRV parameters (e.g., SDNN, RMSSD, LF/HF), and P-wave indices.
Data Processing: Daily review of uploaded ECG data to analyze AF events. For participants with suspected AF, further evaluation with a 12-lead ECG or 24-hour Holter monitoring is recommended. HRV parameters will be extracted and analyzed for their correlation with stroke risk.
Acceptability Assessment: The acceptability of the device among participants and healthcare providers will be assessed through quantitative and qualitative methods. Quantitative data include device wear time and interruption rates, while qualitative data are collected through questionnaires and semi-structured interviews.
Outcome Measures:
Primary Outcomes: AF detection rate of the wearable ECG garment; correlation between HRV parameters (e.g., SDNN, RMSSD, LF/HF) and stroke risk.
Secondary Outcomes: Correlation between P-wave indices and AF; acceptability of the device among patients and healthcare providers; incidence of stroke and composite vascular events (e.g., myocardial infarction, heart failure, vascular death) during long-term follow-up.
Follow-up Plan:
Participants will be followed up at 6 and 12 months after enrollment to record the occurrence of stroke, AF, and other cardiovascular events.
Statistical Analysis:
Data will be analyzed using SPSS 25.0. Normally distributed continuous variables will be expressed as mean ± standard deviation, while non-normally distributed variables will be expressed as median and interquartile range. Group comparisons will be made using t-tests or chi-square tests, and correlation analyses will be performed using Pearson or Spearman rank correlation. Predictive factors for AF events and other outcomes will be determined through multivariate competing risk analysis.
Data Management:
All data will be entered into an electronic case report form (eCRF) and uploaded to a cloud database in real time. The research team will regularly review the completeness and accuracy of the data to ensure data quality.
Safety Assessment:
The safety of device use will be assessed, including the comfort of long-term wear and the incidence of adverse reactions (e.g., skin allergies or local irritation). The impact of false positives or false negatives on medical decision-making will also be evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High-Risk Stroke Cohort with Wearable ECG Garment | – | Device: Wearable ECG Garment for Continuous Atrial Fibrillation Screening and Stroke Risk AssessmentThis cohort consists of individuals aged 40 and above who are at high risk of stroke, as determined by the "8+2" stroke risk score. Participants will wear a wearable ECG garment for 24-hour continuous ECG monitoring to detect atrial fibrillation (AF) and assess stroke risk. The device will record heart rate, rhythm, HRV parameters (e.g., SDNN, RMSSD, LF/HF), and P-wave indices. The study aims to evaluate the accuracy of the wearable ECG garment in AF detection, explore the correlation between HRV parameters and stroke risk, and assess the acceptability of the device among patients and healthcare providers. Participants will undergo follow-up at 6 and 12 months to monitor the occurrence of stroke, AF, and other cardiovascular events. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of individuals aged 40 years and above who are identified as high-risk for stroke based on the "8+2" stroke risk score. This population includes individuals with elevated stroke risk factors such as hypertension, diabetes, smoking history, and family history of stroke. Participants must be able to operate the wearable ECG garment independently or with assistance from family members and must provide informed consent to participate in the study. The study aims to enroll 243 participants to ensure sufficient statistical power for evaluating the accuracy of the wearable ECG garment in detecting atrial fibrillation (AF) and assessing stroke risk.
Key inclusion criteria (4 listed)
- Age ≥ 40 years.
- High-risk stroke population identified by the "8+2" risk score in stroke screening.
- Ability to operate the device independently or with assistance from family members.
- Willingness to participate in the study and provide signed informed consent.
Key exclusion criteria (4 listed)
- Patients with severe diseases that limit device wear (e.g., advanced malignant tumors, severe infections, Class IV heart failure) or those receiving hospice care.
- Patients unable to operate the device or understand the study procedures due to cognitive impairment, mental illness, or language communication barriers.
- Patients who may experience severe discomfort or allergic reactions from wearing the device.
- Patients already using implanted cardiac monitoring devices.
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 |
|---|---|---|
| Wearable ECG Garment for Continuous Atrial Fibrillation Screening and Stroke Risk AssessmentThis intervention utilizes a wearable ECG garment, a non-invasive, textile-based device for continuous 24-hour ECG monitoring. The garment features embedded electrodes to capture heart rate, rhythm, HRV parameters (e.g., SDNN, RMSSD, LF/HF), and P-wave indices (e.g., P-wave duration, PtfV1), enabling comprehensive assessment of atrial fibrillation (AF) and stroke risk. The device is lightweight, comfortable, and supports wireless data transmission to the cloud for real-time analysis. The study incorporates machine learning algorithms to identify AF patterns and explore stroke risk predictors, targeting individuals aged 40+ at high stroke risk. It also evaluates device acceptability and usability, aiming to improve AF detection rates, enable early intervention, and reduce stroke risk. | Device | High-Risk Stroke Cohort with Wearable ECG Garment |
Primary outcome
Atrial Fibrillation Detection Rate in Stroke High-Risk Populations Using Wearable ECG Garment
Time frame: Baseline to 12 months: Continuous 24-hour ECG monitoring at baseline, with follow-up at 6 and 12 months to assess AF.
1.Atrial Fibrillation (AF) Detection Rate: The proportion of AF cases identified by the wearable ECG garment in the high-risk stroke population during 24-hour continuous monitoring.
Correlation Between HRV Parameters and Stroke Risk in High-Risk Populations Using Wearable ECG Garment
Time frame: Baseline to 12 months: Continuous 24-hour ECG monitoring at baseline, with follow-up at 6 and 12 months to assess stroke.
Correlation Between HRV Parameters and Stroke Risk: Analysis of key HRV parameters (e.g., SDNN, RMSSD, LF/HF) to assess their association with AF and stroke risk in high-risk individuals.
3 secondary outcomes
Development of an AF Risk Prediction Model Using P-Wave Indices in High-Risk Stroke Populations
Time frame: P-wave indices collected during 24-hour ECG monitoring at baseline, with model validation using follow-up data at 6 and 12 months.
Patient and Healthcare Provider Acceptability of Wearable ECG Garment
Time frame: Baseline to 12 months: Acceptability assessed at baseline (after initial use) and during follow-up visits at 6 and 12 months.
Incidence of Stroke, AF, and Composite Vascular Events During Long-Term Follow-Up
Time frame: Baseline to 12 months: Continuous 24-hour ECG monitoring at baseline, with follow-up assessments at 6 and 12 months to track clinical outcomes.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared to protect participant privacy and confidentiality. The data contain sensitive personal health information, and sharing it publicly could compromise participant anonymity. Additionally, the informed consent process did not include provisions for public data sharing, and releasing the data could violate participant consent agreements. The data are solely intended for use by the research team to achieve the study objectives."
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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.
Jian Wu, MD. study chair
BeijingTsinghua Changgung Hospital, School of Clinical Medicine,Tsinghua Medicine, Tsinghua University
Yating Wu, MD. principal investigator
BeijingTsinghua Changgung Hospital, School of Clinical Medicine,Tsinghua Medicine, Tsinghua University
Yifei Chen, MD. principal investigator
Pinggu District Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Stroke, run by Beijing Tsinghua Chang Gung Hospital at 2 sites 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 4 inclusion and 4 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: opening soon, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yating Wu, MD. (+86 56119526, wuyating926@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Atrial Fibrillation Detection Rate in Stroke High-Risk Populations Using Wearable ECG Garment (time frame: Baseline to 12 months: Continuous 24-hour ECG monitoring at baseline, with follow-up at 6 and 12 months to assess AF.). 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?
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 2 Apr 2025.