Atrial FibrillationNCT07173673
A Prospective, Multi-center, Randomized Clinical Trial to Evaluate the Detection of Atrial Fibrillation Using Artificial Intelligence-Enhanced Electrocardiography (SmartECG-AFrisk) Compared With Usual Care in Patients With Suspected Atrial Fibrillation: DEEP-AF
A study testing AI-ECG Guided Care (SmartECG-AFrisk) in people with Atrial Fibrillation, run by Yonsei University at 1 site in South Korea.
Trial summary
"The DEEP-AF study is a prospective, multi-center, randomized clinical trial evaluating the effectiveness of an artificial intelligence-enhanced electrocardiography algorithm (SmartECG-AFrisk) for early detection of atrial fibrillation (AF) in adults with suspected AF but no prior diagnosis. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- AI-ECG Guided Care (SmartECG-AFrisk)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,230 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2025to 30 Nov 2027
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults ≥30 years old
- - Symptoms suggestive of atrial fibrillation (palpitations, dizziness, syncope, dyspnea, chest discomfort)
- - No evidence of AF on baseline 12-lead ECG
- - No prior history of AF diagnosis
Who cannot join
- - Prior diagnosis of atrial fibrillation
- - Life expectancy ≤ 1 year
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Yonsei University College of Medicine
Seoul
Hee Tae yu, MD, +82-2-2228-8460, heetyu@yuhs.ac
About this study
"The DEEP-AF study is a prospective, multi-center, randomized clinical trial evaluating the effectiveness of an artificial intelligence-enhanced electrocardiography algorithm (SmartECG-AFrisk) for early detection of atrial fibrillation (AF) in adults with suspected AF but no prior diagnosis. A total of 1,230 participants will be enrolled across 13 centers in Korea and randomized 1:1 into standard care or AI-guided care arms.
In the standard care arm, diagnostic evaluation follows clinical guidelines with symptom-based use of 12-lead ECG, Holter, or patch ECG. In the AI-guided arm, baseline 12-lead ECGs are analyzed using SmartECG-AFrisk to calculate an AF risk score. Participants are classified as high-risk (score ≥50) or low-risk (<50), and monitoring strategies are determined accordingly, enabling targeted ECG monitoring for high-risk individuals.
Read more
The primary objective is to compare the 6-month incidence of newly diagnosed AF between the two arms. Secondary endpoints include AF detection differences between risk groups, healthcare resource utilization per AF diagnosis, anticoagulation initiation rates, major clinical events (stroke, embolism, bleeding, mortality), and patient satisfaction.
This study aims to demonstrate whether integrating AI-driven ECG risk stratification into routine care improves AF detection and optimizes healthcare resource use in real-world clinical practice.
- Conditions
- Atrial Fibrillation
- Being tested
- Usual Care (General Practice), AI-ECG Guided Care (SmartECG-AFrisk)
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual Care (General Practice)Other
Participants receive routine care based on current clinical guidelines. Symptom-driven evaluation is performed by physicians, including at least one diagnostic test within 6 months such as a standard 12-lead ECG, Holter monitoring, or patch ECG. The choice and frequency of monitoring are determined by physician discretion, reflecting real-world practice patterns.
AI-ECG Guided Care (SmartECG-AFrisk)Device
Participants undergo SmartECG-AFrisk analysis of baseline 12-lead ECGs recorded in sinus rhythm. The algorithm calculates an atrial fibrillation risk score, classifying participants as high-risk (score ≥50) or low-risk (<50). Monitoring strategies are adapted accordingly: high-risk participants undergo targeted and potentially repeated ECG monitoring using 12-lead ECG, Holter, or patch ECG, while low-risk participants follow standard guideline-based care.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care (General Practice) | Active comparator | Symptom-based evaluation by physicians, including 12-lead ECG, Holter monitoring, or patch ECG at least once within 6 months Receives: Other: Usual Care (General Practice) |
| AI-ECG Guided Care (SmartECG-AFrisk) | Experimental | Monitoring strategy determined by SmartECG-AFrisk risk score (≥50 = high-risk vs <50 = low-risk). Receives: Device: AI-ECG Guided Care (SmartECG-AFrisk) |
What is being measured
The primary outcome is the main question the study is designed to answer.
New diagnosis of atrial fibrillation within 6 months. (confirmed by ECG, Holter, or patch ECG)
Measured: Baseline (randomization) to 6 months after enrollment. Event date is defined as the first ECG/Holter/patch ECG documenting AF during the 6-month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study startNov 2025 (estimated)
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Nov 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 Yonsei UniversityThe 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
- Masking
- None (open label)
- Enrolment
- 1,230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07173673
- Sponsor's protocol ID
- 1-2024-0069
- Status last verified
- Sep 2025
- First submitted
- 7 Sep 2025
- Last updated
- 15 Sep 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 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center, Randomized Clinical Trial to Evaluate the Detection of Atrial Fibrillation Using Artificial Intelligence-Enhanced Electrocardiography (SmartECG-AFrisk) Compared With Usual Care in Patients With Suspected Atrial Fibrillation: DEEP-AF
- ClinicalTrials.gov ID
- NCT07173673
- Acronym / sponsor ID
- 1-2024-0069
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,230 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Nov 2025 (estimated)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 15 Sep 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.
"The DEEP-AF study is a prospective, multi-center, randomized clinical trial evaluating the effectiveness of an artificial intelligence-enhanced electrocardiography algorithm (SmartECG-AFrisk) for early detection of atrial fibrillation (AF) in adults with suspected AF but no prior diagnosis. A total of 1,230 participants will be enrolled across 13 centers in Korea and randomized 1:1 into standard care or AI-guided care arms.
In the standard care arm, diagnostic evaluation follows clinical guidelines with symptom-based use of 12-lead ECG, Holter, or patch ECG. In the AI-guided arm, baseline 12-lead ECGs are analyzed using SmartECG-AFrisk to calculate an AF risk score. Participants are classified as high-risk (score ≥50) or low-risk (<50), and monitoring strategies are determined accordingly, enabling targeted ECG monitoring for high-risk individuals.
The primary objective is to compare the 6-month incidence of newly diagnosed AF between the two arms. Secondary endpoints include AF detection differences between risk groups, healthcare resource utilization per AF diagnosis, anticoagulation initiation rates, major clinical events (stroke, embolism, bleeding, mortality), and patient satisfaction.
This study aims to demonstrate whether integrating AI-driven ECG risk stratification into routine care improves AF detection and optimizes healthcare resource use in real-world clinical practice.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care (General Practice) | Active comparator | Other: Usual Care (General Practice)Symptom-based evaluation by physicians, including 12-lead ECG, Holter monitoring, or patch ECG at least once within 6 months |
| AI-ECG Guided Care (SmartECG-AFrisk) | Experimental | Device: AI-ECG Guided Care (SmartECG-AFrisk)Monitoring strategy determined by SmartECG-AFrisk risk score (≥50 = high-risk vs <50 = low-risk). |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults ≥30 years old
- - Symptoms suggestive of atrial fibrillation (palpitations, dizziness, syncope, dyspnea, chest discomfort)
- - No evidence of AF on baseline 12-lead ECG
- - No prior history of AF diagnosis
Key exclusion criteria (2 listed)
- - Prior diagnosis of atrial fibrillation
- - Life expectancy ≤ 1 year
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 |
|---|---|---|
| Usual Care (General Practice)Participants receive routine care based on current clinical guidelines. Symptom-driven evaluation is performed by physicians, including at least one diagnostic test within 6 months such as a standard 12-lead ECG, Holter monitoring, or patch ECG. The choice and frequency of monitoring are determined by physician discretion, reflecting real-world practice patterns. | Other | Usual Care (General Practice) |
| AI-ECG Guided Care (SmartECG-AFrisk)Participants undergo SmartECG-AFrisk analysis of baseline 12-lead ECGs recorded in sinus rhythm. The algorithm calculates an atrial fibrillation risk score, classifying participants as high-risk (score ≥50) or low-risk (<50). Monitoring strategies are adapted accordingly: high-risk participants undergo targeted and potentially repeated ECG monitoring using 12-lead ECG, Holter, or patch ECG, while low-risk participants follow standard guideline-based care. | Device | AI-ECG Guided Care (SmartECG-AFrisk) |
Primary outcome
New diagnosis of atrial fibrillation within 6 months. (confirmed by ECG, Holter, or patch ECG)
Time frame: Baseline (randomization) to 6 months after enrollment. Event date is defined as the first ECG/Holter/patch ECG documenting AF during the 6-month follow-up.
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 15 Sep 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-ECG Guided Care (SmartECG-AFrisk) in people with Atrial Fibrillation, run by Yonsei University at 1 site in South Korea.
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 2 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 15 Sep 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 South Korea. 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 Hee Tae Yu, MD (+82-2-2228-8460, heetyu@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
New diagnosis of atrial fibrillation within 6 months. (confirmed by ECG, Holter, or patch ECG) (time frame: Baseline (randomization) to 6 months after enrollment. Event date is defined as the first ECG/Holter/patch ECG documenting AF during the 6-month follow-up.). 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 15 Sep 2025.