Atrial FibrillationAI-AFISNCT07540065
AI-Assisted Workflow for Occult Atrial Fibrillation Detection After Ischemic Stroke: A Prospective Randomized Trial
A study testing Active Follow-up Group and Standard Follow-up Group in people with Atrial Fibrillation and Stroke, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
We hypothesize that an AI-guided AF risk stratification approach, particularly when combined with intensified rhythm monitoring using wearable devices and extended ECG patches, will significantly increase AF detection rates compared with standard care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Stroke, Artificial Intelligence
- What is being tested?
- Active Follow-up Group and Standard Follow-up Group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Oct 2026to 31 Dec 2028
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older who are acutely hospitalized due to ischemic stroke;
- A 12-lead electrocardiogram upon admission showing sinus rhythm;
Who cannot join
- Previous diagnosis of atrial fibrillation or flutter;
- Diagnosis of atrial fibrillation during hospitalization;
- Pre-existing cardiac implantable electronic device (IVD);
- Expected inability to attend regular outpatient follow-ups after discharge, or to undergo multiple 14-day ECG recordings;
- Requires long-term anticoagulant use for other reasons, including but not limited to chronic pulmonary embolism;
- Known contraindications to non-vitamin K antagonist oral anticoagulants due to comorbidities, including but not limited to end-stage renal disease, severe mitral stenosis due to rheumatic heart disease, or metallic heart valves;
- Unwilling to sign a participant consent form.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
HSIAO-HAN HUANG contact
Taiwan1 site
National Taiwan University Hospita
Taipei, 100
Chih-Chieh Yu, MD.PhD, 0972652038, sweetchieh@gmail.com
HSIAO-HAN, clrhuang8853@gmail.com
About this study
We hypothesize that an AI-guided AF risk stratification approach, particularly when combined with intensified rhythm monitoring using wearable devices and extended ECG patches, will significantly increase AF detection rates compared with standard care. By enabling earlier identification of patients who may benefit from anticoagulation therapy, this strategy has the potential to improve clinical outcomes while minimizing unnecessary exposure to anticoagulant-related bleeding risks. Ultimately, this trial seeks to provide robust clinical evidence supporting the integration of AI-assisted ECG analysis into routine post-stroke care, advancing precision medicine and optimizing resource allocation for patients with ischemic stroke.
Read the detailed description
This study is designed as a multicenter, prospective, randomized controlled trial enrolling adult patients hospitalized for acute ischemic stroke who demonstrate sinus rhythm on admission 12-lead ECG. Participants will be randomized to either an AI-assisted care group or a usual-care control group, and further allocated to active or standard rhythm monitoring strategies. The primary endpoint is the incidence of newly diagnosed AF or atrial flutter within six months, defined by electrocardiographic documentation. Secondary and exploratory endpoints include the rate of oral anticoagulant initiation, AF burden metrics, recurrent embolic events, bleeding complications, major adverse cardiovascular events, cognitive outcomes, and all-cause mortality.
- Conditions
- Atrial Fibrillation, Stroke, Artificial Intelligence
- Being tested
- Active Follow-up Group, Standard Follow-up Group
- Keywords
- stroke, atrial fibrillation, artificial intelligence, risk prediction, electrocardiogram, non-vitamin K antagonist oral anticoagulants
- 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.
Active Follow-up GroupDevice
Also called smartwatch, electrocardiogram
High-frequency electrocardiogram (ECG) monitoring was conducted, using a smartwatch with continuous photoplethysmography (PPG) monitoring, supplemented by an external single-lead ECG patch for 14 days. Participants recorded ECGs for 14 days immediately after discharge. If the smartwatch detected atrial fibrillation, the patch would be automatically applied for 14 days of recording. After recording, the patch was mailed or delivered in person to the research team for analysis.
Standard Follow-up GroupOther
Also called standardized follow-up procedure
followed a standardized follow-up procedure by a neurologist. Each follow-up visit included a medical history and physical examination, without further cardiac-related monitoring. However, if the patient presented with symptoms of arrhythmia, the physician could consult a cardiologist or perform a preliminary 12-lead ECG.
| Study group | Role | What they receive |
|---|---|---|
| Actively track | Experimental | High-frequency electrocardiogram (ECG) monitoring was conducted, using a smartwatch with continuous photoplethysmography (PPG) and an external monopolar ECG patch for 14 days. Subjects recorded ECGs for 14 days immediately after discharge. If the smartwatch detected atrial fibrillation, it would automatically apply the ECG patch for 14 days to record the data. After recording, the data was mailed or delivered in person to the research team for analysis. Receives: Device: Active Follow-up Group |
| Standard Tracking Group | Active comparator | Following the standardized follow-up procedure for neurologists, each follow-up visit includes a medical history and physical examination, without further cardiac-related monitoring. However, if the patient has symptoms of arrhythmia, the physician may consult a cardiologist or perform a preliminary 12-lead electrocardiogram. Receives: Other: Standard Follow-up Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference betwee Active Group & Standard Group
The difference between the probability of a new diagnosis of atrial fibrillation or atrial flutter within six months (defined as an atrial fibrillation waveform longer than 30 seconds on a single-lead ECG or a twelve-lead ECG) in subjects identified as high-risk in the AI-assisted group and those who were actively followed up (Group A) and those who were followed up according to standard care (Group D).
Measured: 400DAYS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start1 Oct 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (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 National Taiwan University 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective randomized trial will enroll acute ischemic stroke patients with sinus rhythm at admission. Patients will be randomly assigned to either an intensive monitoring group, guided by the AI model, or a standard care group. High-risk patients identified by the AI model will undergo high density, 14-day external single-lead ECG monitoring, analyzed for AF episodes. Both groups will receive standard neurological follow-up. Primary outcomes include new-onset AF detection and recurrent stroke incidence, while secondary outcomes include AF burden, mortality, cognitive function, and healthcare resource utilization.
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07540065
- Sponsor's protocol ID
- 202601103RIND
- Acronym
- AI-AFIS
- Status last verified
- Apr 2026
- First submitted
- 7 Jan 2026
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AI-Assisted Workflow for Occult Atrial Fibrillation Detection After Ischemic Stroke: A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT07540065
- Acronym / sponsor ID
- AI-AFIS / 202601103RIND
- Conditions
- Atrial Fibrillation, Stroke, Artificial Intelligence
- Keywords
- stroke, atrial fibrillation, artificial intelligence, risk prediction, electrocardiogram, non-vitamin K antagonist oral anticoagulants
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 20 Apr 2026 (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.
We hypothesize that an AI-guided AF risk stratification approach, particularly when combined with intensified rhythm monitoring using wearable devices and extended ECG patches, will significantly increase AF detection rates compared with standard care. By enabling earlier identification of patients who may benefit from anticoagulation therapy, this strategy has the potential to improve clinical outcomes while minimizing unnecessary exposure to anticoagulant-related bleeding risks. Ultimately, this trial seeks to provide robust clinical evidence supporting the integration of AI-assisted ECG analysis into routine post-stroke care, advancing precision medicine and optimizing resource allocation for patients with ischemic stroke.
Detailed description
This study is designed as a multicenter, prospective, randomized controlled trial enrolling adult patients hospitalized for acute ischemic stroke who demonstrate sinus rhythm on admission 12-lead ECG. Participants will be randomized to either an AI-assisted care group or a usual-care control group, and further allocated to active or standard rhythm monitoring strategies. The primary endpoint is the incidence of newly diagnosed AF or atrial flutter within six months, defined by electrocardiographic documentation. Secondary and exploratory endpoints include the rate of oral anticoagulant initiation, AF burden metrics, recurrent embolic events, bleeding complications, major adverse cardiovascular events, cognitive outcomes, and all-cause mortality.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A prospective randomized trial will enroll acute ischemic stroke patients with sinus rhythm at admission. Patients will be randomly assigned to either an intensive monitoring group, guided by the AI model, or a standard care group. High-risk patients identified by the AI model will undergo high density, 14-day external single-lead ECG monitoring, analyzed for AF episodes. Both groups will receive standard neurological follow-up. Primary outcomes include new-onset AF detection and recurrent stroke incidence, while secondary outcomes include AF burden, mortality, cognitive function, and healthcare resource utilization.
| Arm | Type | Receives |
|---|---|---|
| Actively track | Experimental | Device: Active Follow-up GroupHigh-frequency electrocardiogram (ECG) monitoring was conducted, using a smartwatch with continuous photoplethysmography (PPG) and an external monopolar ECG patch for 14 days. Subjects recorded ECGs for 14 days immediately after discharge. If the smartwatch detected atrial fibrillation, it would automatically apply the ECG patch for 14 days to record the data. After recording, the data was mailed or delivered in person to the research team for analysis. |
| Standard Tracking Group | Active comparator | Other: Standard Follow-up GroupFollowing the standardized follow-up procedure for neurologists, each follow-up visit includes a medical history and physical examination, without further cardiac-related monitoring. However, if the patient has symptoms of arrhythmia, the physician may consult a cardiologist or perform a preliminary 12-lead electrocardiogram. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years or older who are acutely hospitalized due to ischemic stroke;
- A 12-lead electrocardiogram upon admission showing sinus rhythm;
Key exclusion criteria (7 listed)
- Previous diagnosis of atrial fibrillation or flutter;
- Diagnosis of atrial fibrillation during hospitalization;
- Pre-existing cardiac implantable electronic device (IVD);
- Expected inability to attend regular outpatient follow-ups after discharge, or to undergo multiple 14-day ECG recordings;
- Requires long-term anticoagulant use for other reasons, including but not limited to chronic pulmonary embolism;
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 |
|---|---|---|
| Active Follow-up GroupAlso: smartwatch, electrocardiogramHigh-frequency electrocardiogram (ECG) monitoring was conducted, using a smartwatch with continuous photoplethysmography (PPG) monitoring, supplemented by an external single-lead ECG patch for 14 days. Participants recorded ECGs for 14 days immediately after discharge. If the smartwatch detected atrial fibrillation, the patch would be automatically applied for 14 days of recording. After recording, the patch was mailed or delivered in person to the research team for analysis. | Device | Actively track |
| Standard Follow-up GroupAlso: standardized follow-up procedurefollowed a standardized follow-up procedure by a neurologist. Each follow-up visit included a medical history and physical examination, without further cardiac-related monitoring. However, if the patient presented with symptoms of arrhythmia, the physician could consult a cardiologist or perform a preliminary 12-lead ECG. | Other | Standard Tracking Group |
Primary outcome
The difference betwee Active Group & Standard Group
Time frame: 400DAYS
The difference between the probability of a new diagnosis of atrial fibrillation or atrial flutter within six months (defined as an atrial fibrillation waveform longer than 30 seconds on a single-lead ECG or a twelve-lead ECG) in subjects identified as high-risk in the AI-assisted group and those who were actively followed up (Group A) and those who were followed up according to standard care (Group D).
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 20 Apr 2026.
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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.
HSIAO-HAN HUANG contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Follow-up Group and Standard Follow-up Group in people with Atrial Fibrillation and Stroke, run by National Taiwan University Hospital at 1 site in Taiwan.
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 2 inclusion and 7 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 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. 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 Chih-Chieh Yu, MD.PhD (0972652038, sweetchieh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference betwee Active Group & Standard Group (time frame: 400DAYS). 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 20 Apr 2026; AzTrials last refreshed its copy on 6 Nov 2026.