Atrial Fibrillation (AF)LATENTNCT06847932
Leveraging AI-ECG Technology for Early Notification and Tracking of AF Development
A study testing AF-predict AI-ECG alert system guided management in people with Atrial Fibrillation (AF) and Premature Atrial Complexes, run by National Defense Medical Center, Taiwan at 1 site in Taiwan.
Trial summary
Our study aimed to use an AF-predict AI-ECG alert system to help physicians identify patients who need to wear a continuous cardiac rhythm monitor for new diagnoses of atrial fibrillation (AF), atrial flutter (AFL), or atrial arrhythmia with high AF risk, including premature atrial complexes (PAC) ≥ 500/24hr, burst… Read more about this study
- Who is it for?
- Ages 40 to 85 days
- Conditions the study is for
- Atrial Fibrillation (AF), Premature Atrial Complexes, Atrial Arrhythmias
- What is being tested?
- AF-predict AI-ECG alert system guided management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14,726 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jul 2025to 1 Oct 2026
- 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 40 to 85 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients in the inpatient department or the outpatient department
- Patients need to have at least one electrocardiogram within one year
Who cannot join
- Diagnosis of atrial fibrillation/atrial flutter
- History of atrial fibrillation/atrial flutter catheter ablation
- Patients with cardiac implantable electronic devices
- Any documented electrocardiogram showed atrial fibrillation/atrial flutter and pacing rhythm
- History of received rhythm control medications for atrial arrhythmia, including Class I and Class III antiarrhythmic drugs
- Any reasons indicate for anti-coagulant agents, including vitamin K antagonist and non-vitamin K antagonist oral anticoagulant
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Tri-Service General Hospital
Taipei, 114
Yuan-Hao Chen, +886287923311, chenyh178@gmail.com
Chin Lin, PhD
About this study
Official title: Leveraging AI-ECG Technology for Early Notification and Tracking of AF Development: a Randomized Control Trial
Our study aimed to use an AF-predict AI-ECG alert system to help physicians identify patients who need to wear a continuous cardiac rhythm monitor for new diagnoses of atrial fibrillation (AF), atrial flutter (AFL), or atrial arrhythmia with high AF risk, including premature atrial complexes (PAC) ≥ 500/24hr, burst PACs > 20 beats, non-sustained AF/AFL.
- Conditions
- Atrial Fibrillation (AF), Premature Atrial Complexes, Atrial Arrhythmias, Artificial Intelligence (AI), Electrocardiogram
- Being tested
- AF-predict AI-ECG alert system guided management
- Medical subject headings
- Atrial Fibrillation, Atrial Premature Complexes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AF-predict AI-ECG alert system guided managementOther
AF-predict AI-ECG alert system
| Study group | Role | What they receive |
|---|---|---|
| AF-predict AI-ECG alert system | Experimental | All the patients' ECGs will receive AF-predict AI-ECG analysis. According to the AI-ECG analysis results, those with at least one high-risk ECG within one year will be called back and asked to undergo a continuous cardiac rhythm monitor for up to 7 days. Otherwise, the physicians can review the AI-ECG analysis results for all the patients in the intervention group. Receives: Other: AF-predict AI-ECG alert system guided management |
| Standard of care | No intervention | Patients will receive the standard care, and their ECGs will not be analyzed by AI-ECG before the end of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Latent atrial fibrillation
The primary outcome, latent atrial fibrillation, is a composite of new diagnoses of AF/AFL, atrial arrhythmia with high AF risk, including PACs ≥ 500/24hr, burst PACs > 20 beats, and non-sustained AF/AFL, within 90 days after enrollment. The results will be demonstrated as the rate of diagnoses of latent atrial fibrillation.
Measured: Within 90 days after enrollment.
Secondary outcomes (3)
Antiarrhythmic treatment
Antiarrhythmic treatment may include newly prescribed beta-blockers or non-dihydropyridine calcium channel blockers, class Ia, Ic, and III antiarrhythmic drugs, and catheter ablation. Physicians can determine whether a patient requires antiarrhythmic treatment through clinical practice. The outcome is the rate of initiation of antiarrhythmic treatment.
Measured: Within 180 days after enrollment.
90-days New diagnoses of atrial fibrillation/atrial flutter
New diagnoses of atrial fibrillation or atrial flutter are defined as those documented by a 12-lead electrocardiogram or by continuous cardiac rhythm monitoring for ≥ 30 seconds. The result will be presented as the rate of new diagnoses of atrial fibrillation or atrial flutter.
Measured: Within 90 days after enrollment.
Atrial arrhythmia with high AF risk
Atrial arrhythmia with high AF risk is defined by the following criteria: premature atrial complexes more than 500 beats in 24 hours as recorded by a continuous cardiac rhythm monitor; burst premature atrial complexes exceeding 20 beats as documented in a continuous cardiac rhythm monitor or a 12-lead electrocardiogram, or documented non-sustained AF/AFL in either a continuous cardiac rhythm monitor or a 12-lead electrocardiogram. The result will be presented as the rate of diagnoses of atrial arrhythmia with high AF risk.
Measured: Within 90 days after enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2025
- Study start1 Jul 2025
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14,726 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Defense Medical Center, Taiwan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chin Lin, National Defense Medical Center, Taiwan
- Investigators
- Chin Lin, PhD, Principal investigator, National Defense Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06847932
- Sponsor's protocol ID
- A202205179
- Acronym
- LATENT
- Status last verified
- Nov 2025
- First submitted
- 21 Feb 2025
- Last updated
- 19 Nov 2025
- 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 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leveraging AI-ECG Technology for Early Notification and Tracking of AF Development: a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06847932
- Acronym / sponsor ID
- LATENT / A202205179
- Conditions
- Atrial Fibrillation (AF), Premature Atrial Complexes, Atrial Arrhythmias, Artificial Intelligence (AI), Electrocardiogram
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 14,726 participants (estimated)
- Lead sponsor
- National Defense Medical Center, TaiwanUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 26 Feb 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.
Our study aimed to use an AF-predict AI-ECG alert system to help physicians identify patients who need to wear a continuous cardiac rhythm monitor for new diagnoses of atrial fibrillation (AF), atrial flutter (AFL), or atrial arrhythmia with high AF risk, including premature atrial complexes (PAC) ≥ 500/24hr, burst PACs > 20 beats, non-sustained AF/AFL.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AF-predict AI-ECG alert system | Experimental | Other: AF-predict AI-ECG alert system guided managementAll the patients' ECGs will receive AF-predict AI-ECG analysis. According to the AI-ECG analysis results, those with at least one high-risk ECG within one year will be called back and asked to undergo a continuous cardiac rhythm monitor for up to 7 days. Otherwise, the physicians can review the AI-ECG analysis results for all the patients in the intervention group. |
| Standard of care | No intervention | –Patients will receive the standard care, and their ECGs will not be analyzed by AI-ECG before the end of the study. |
Who may qualify
- Ages
- 40 to 85 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Patients in the inpatient department or the outpatient department
- Patients need to have at least one electrocardiogram within one year
Key exclusion criteria (6 listed)
- Diagnosis of atrial fibrillation/atrial flutter
- History of atrial fibrillation/atrial flutter catheter ablation
- Patients with cardiac implantable electronic devices
- Any documented electrocardiogram showed atrial fibrillation/atrial flutter and pacing rhythm
- History of received rhythm control medications for atrial arrhythmia, including Class I and Class III antiarrhythmic drugs
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 |
|---|---|---|
| AF-predict AI-ECG alert system guided managementAF-predict AI-ECG alert system | Other | AF-predict AI-ECG alert system |
Primary outcome
Latent atrial fibrillation
Time frame: Within 90 days after enrollment.
The primary outcome, latent atrial fibrillation, is a composite of new diagnoses of AF/AFL, atrial arrhythmia with high AF risk, including PACs ≥ 500/24hr, burst PACs > 20 beats, and non-sustained AF/AFL, within 90 days after enrollment. The results will be demonstrated as the rate of diagnoses of latent atrial fibrillation.
3 secondary outcomes
Antiarrhythmic treatment
Time frame: Within 180 days after enrollment.
90-days New diagnoses of atrial fibrillation/atrial flutter
Time frame: Within 90 days after enrollment.
Atrial arrhythmia with high AF risk
Time frame: Within 90 days after enrollment.
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 19 Nov 2025.
- 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.
Chin Lin, PhD principal investigator
National Defense Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AF-predict AI-ECG alert system guided management in people with Atrial Fibrillation (AF) and Premature Atrial Complexes, run by National Defense Medical Center, Taiwan 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 6 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: looking for participants now, as of the sponsor's last update on 19 Nov 2025. 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 Chin Lin, PhD (+886-2-8792-3100 Ext. 18574, xup6fup@mail.ndmctsgh.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Latent atrial fibrillation (time frame: Within 90 days after enrollment.). 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 19 Nov 2025.