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AI heart check may skip ultrasound for AFib patients

NCT ID NCT07486739

Knowledge-focused Sponsor: Seoul National University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 24, 2026 · Updated 2 times

Summary

This study tests whether an artificial intelligence (AI) analysis of a simple electrocardiogram (ECG) can safely replace routine heart ultrasound (echocardiography) in managing atrial fibrillation (AF). About 1,724 adults with AF will be randomly assigned to either AI-ECG guided care or standard ultrasound-based care. The goal is to see if the AI approach is just as good at preventing serious events like stroke, hospitalization, or death.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 1,724 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

19 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. AF documented by electrocardiography within the past 12 months * AF documented on a 12-lead electrocardiogram or recorded for ≥30 seconds on a single-lead or multi-lead electrocardiogram. 2. Patients for whom an initial or repeat transthoracic echocardiographic evaluation is clinically indicated. 3. A CHA₂DS₂-VA score of ≥2. 4. Aged ≥19 years at the time of enrollment and able to provide written informed consent voluntarily. Exclusion Criteria: 1. Transthoracic echocardiography performed within the past 6 months. 2. Ventricular rate ≥110 beats per minute during atrial fibrillation. 3. Atrial fibrillation due to a reversible cause. 4. New York Heart Association (NYHA) functional class IV or European Heart Rhythm Association (EHRA) class IV symptoms. 5. Known history of structural heart disease or clinical findings suggestive of structural heart disease based on medical history and physical examination. (e.g., presence of a cardiac murmur of Levine scale grade 3 or higher on auscultation, or murmurs suggestive of moderate to severe mitral stenosis, such as an opening snap or diastolic rumbling murmur). 6. Baseline electrocardiographic conduction abnormalities or significant electrocardiographic findings suggestive of clinically meaningful structural heart disease (e.g., Mobitz type II second-degree atrioventricular block, third-degree atrioventricular block, or QTc ≥480 ms). 7. History of prior cardiac surgery. 8. History of acute coronary syndrome or coronary revascularization within the past 90 days. 9. History of intracardiac thrombosis or systemic thromboembolism within the past 90 days. 10. History of transient ischemic attack, ischemic stroke, or intracranial hemorrhage within the past 90 days. 11. History of ventricular tachycardia or ventricular fibrillation. 12. Severe liver disease associated with coagulopathy (e.g., AST or ALT \>3× the upper limit of normal, or total bilirubin \>2× the upper limit of normal). 13. Severe chronic kidney disease (stage V), requiring or imminently requiring dialysis. 14. Contraindication to anticoagulation therapy. 15. Pregnancy, breastfeeding, or planning pregnancy during the study period. 16. Life expectancy of less than 1 year. 17. Current participation in another randomized clinical trial.

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Conditions

The condition(s) this trial relates to.

atrial fibrillation

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Atrial fibrillation (AF)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    28 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Ajou University Hospital

    Suwon, South Korea

  • Asan Medical Center

    Seoul, South Korea

  • Boramae Medical Center

    Seoul, South Korea

  • CHA Bundang Medical Center

    Seongnam, South Korea

  • Chonnam National University Hospital

    Gwangju, South Korea

  • Daegu Catholic University Medical Center

    Daegu, South Korea

  • Dankook University Hospital

    Cheonan, South Korea

  • Dong-A University Hospital

    Busan, South Korea

  • Eunpyeong St. Mary's Hospital

    Seoul, South Korea

  • Ewha Womans University Seoul Hospital

    Seoul, South Korea

  • Gachon University Gil Medical Center

    Incheon, South Korea

  • Gangnam Severance Hospital

    Seoul, South Korea

  • Hallym University Sacred Heart Hospital

    Anyang, South Korea

  • Hanyang University Hospital

    Seoul, South Korea

  • Jeonbuk National University Hospital

    Jeonju, South Korea

  • Kangbuk Samsung Hospital

    Seoul, South Korea

  • Keimyung University Dongsan Hospital

    Daegu, South Korea

  • Korea University Ansan Hospital

    Ansan, South Korea

  • Korea University Guro Hospital

    Seoul, South Korea

  • Kyung Hee University Hospital at Gangdong

    Seoul, South Korea

  • Kyung Hee University Medical Center

    Seoul, South Korea

  • Kyungpook National University Chilgok Hospital

    Daegu, South Korea

  • Presbyterian Medical Center (Jesus Hospital)

    Jeonju, South Korea

  • Pusan National University Yangsan Hospital

    Yangsan, South Korea

  • Samsung Changwon Hospital

    Changwon, South Korea

  • Samsung Medical Center

    Seoul, South Korea

  • Seoul National University Hospital

    Seoul, South Korea

  • Severance Hospital

    Seoul, South Korea

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