An interventional study of 7-day continuous ECG patch monitor and Six-lead handheld electrocardiogram device in Atrial Fibrillation (AF), sponsored by Seoul St. Mary's Hospital. Recruiting at 5 sites in South Korea. Open to participants aged 20 Years to 79 Years. Per ClinicalTrials.gov, last updated 2026-06-11.
Sponsored by Seoul St. Mary's Hospital · Not applicable, Interventional, and Diagnostic
Among 207 studies in Atrial Fibrillation with a site in Korea, Republic of — 59 open to participants now, 67 under way, 2 of them phase 3. Atrial Fibrillation · Korea, Republic of.
Among the 207 studies in Atrial Fibrillation with a site in Korea, Republic of, this one is the 39th largest by planned enrollment of the 142 interventional ones that give a count, is one of 11 that started in 2024, is one of 89 with no phase, reaches primary completion later than 21 of the 66 other live ones, and was the 195th registered.
4,009 studies on the registry are indexed under Atrial Fibrillation; 961 are open to participants now.
This study's planned enrollment of 800 is above the median of 150 across 2,476 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →59 of the 207 studies in Atrial Fibrillation with a site in Korea, Republic of are open now.
A study can be open while its sites in Korea, Republic of have not opened yet or have stopped. Only those recruiting at a site in Korea, Republic of →
Of the 612 Atrial Fibrillation studies recruiting now, 407 (67%) set no upper age limit and 44 (7%) stop at 75 or younger; 21 take children under 18; 43 take healthy volunteers.
This study: 20 Years to 79 Years · all sexes · no healthy volunteers.
The full table on the hub →207 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 7 · Phase 3 22 · Phase 4 22
First in 2005; this study’s year is marked. 11 started in 2024.
Median enrollment 299 across the 142 interventional studies, 1,181 across the 65 observational. Of the 100 that completed or were terminated, 33 (33%) have results posted.
60 of 207 have an industry lead sponsor. The 10 most frequent:
Seoul St. Mary's Hospital is the lead sponsor of 75 studies on the registry; 8 are open to participants now.
Seoul St. Mary's Hospital has 1 study filed under Atrial Fibrillation — fewer than ten, so there is no comparison to draw.
10 of the studies in Atrial Fibrillation with a site in Korea, Republic of that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05757869Phase 3Janssen Research & Development, LLCA Study of Milvexian Versus Apixaban in Participants With Atrial Fibrillation | 2026-12-08 |
| NCT07641582Seoul St. Mary's HospitalPrediction of Atrial Fibrillation Using Polygenic Risk Score | 2026-12-30 |
| NCT05507749Seoul National University HospitalCyroablation for Pulmonary Vein Isolation Alone in Patients With Early Persistent AF Assessed by Continuous Monitoring | 2026-12-31 |
| NCT05794386Seoul National University HospitalSCAR Burden of Left Atrium Guided cathEter Ablation sTrategy for Persistent Atrial Fibrillation | 2026-12-31 |
| NCT07607093Samsung Medical CenterEfficacy of Early Rhythm Control in AF With TR Patients | 2027-02-28 |
Among the 207 studies in Atrial Fibrillation with a site in Korea, Republic of, from their registry updates:
The goal of this clinical trial is to learn whether a genetic risk score can help identify undiagnosed atrial fibrillation (AF) in adults who may have it. AF is an irregular heartbeat that raises the risk of stroke if not treated early.
The main questions it aims to answer are:
Can a polygenic risk score (PRS) - a score based on a person's genes - identify who is more likely to have AF? Does combining PRS with a person's medical history predict AF better than using medical history alone?
Participants will:
Wear a continuous ECG patch for 7 days to record heart rhythm Give a blood sample for genetic testing to calculate their PRS Use a six-lead handheld ECG device (HATIV® P30, VUNO Inc., Seoul, Republic of Korea) to check their own heart rhythm at home once or twice a week for 1 year Visit the clinic 5 times over 1 year
Researchers will use the genetic and clinical information collected to build a scoring system that predicts who is at risk for AF.
Atrial fibrillation (AF) is the most common cardiac arrhythmia worldwide, affecting approximately 34 million individuals. While early diagnosis and treatment can significantly reduce the risk of stroke, paroxysmal AF often goes undetected due to its intermittent nature. Current screening guidelines lack clear recommendations on which populations benefit most from AF screening and what screening strategies are optimal.
Genome-wide association studies have identified numerous genetic loci associated with AF susceptibility, and the SNP heritability of AF has been estimated at approximately 22%. A polygenic risk score (PRS) aggregates the effects of thousands of common genetic variants across the genome to estimate an individual's genetic predisposition to AF. Prior studies have demonstrated that PRS can stratify AF risk independently of conventional clinical risk factors, suggesting its potential utility in targeted screening strategies.
Genetic Assessment At enrollment, a blood sample of 5cc is collected for DNA extraction via centrifugation. A SNP array is performed using a commercially available SNP chip kit. The resulting genotype data are used to calculate a weighted PRS for AF based on previously published genome-wide association study results.
ECG Monitoring In addition to standard 12-lead ECG and 7-day continuous ECG patch monitoring performed at enrollment, all participants are provided with a six-lead handheld ECG device (HATIV® P30, VUNO Inc., Seoul, Republic of Korea). Participants perform self-ECG recordings at least once or twice per week and additionally upon symptom onset for 1 year after enrollment.
Prediction Model Development At the end of follow-up, participants are classified into AF-diagnosed and non-AF groups. A scoring system integrating clinical history and PRS will be developed to predict AF occurrence and its predictive performance will be evaluated.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants at risk for atrial fibrillation undergo 7-day continuous ECG patch monitoring and SNP array genotyping at enrollment, followed by 1-year self-monitoring with a six-lead handheld ECG device (HATIV® P30, VUNO Inc.).
Device: 7-day continuous ECG patch monitor · Device: Six-lead handheld electrocardiogram device · Genetic: SNP array genotyping
Continuous ECG patch worn for 7 days at enrollment to detect atrial fibrillation and other arrhythmias.
Six-lead ECG device used for self-monitoring at least once or twice weekly and upon symptoms for 1 year.
Also known as: HATIV® P30
DNA extracted from a 5cc blood sample is used to perform SNP array genotyping. The resulting data are used to calculate a polygenic risk score (PRS) for atrial fibrillation based on previously published genome-wide association study results.
Incidence of newly diagnosed atrial fibrillation
New diagnosis of atrial fibrillation confirmed by 7-day continuous ECG patch monitor, six-lead handheld ECG device, or standard 12-lead ECG during the 1-year follow-up period.
Time frame: 1 year
Incidence of newly diagnosed atrial flutter
New diagnosis of atrial flutter confirmed by ECG monitoring during the 1-year follow-up period.
Time frame: 1 year
Predictive performance of the AF prediction model
Discrimination and calibration of a scoring system integrating polygenic risk score and clinical risk factors for predicting atrial fibrillation, assessed by area under the receiver operating characteristic curve (AUC).
Time frame: 1 year
Plan to share: No
Started Nov 2024 (actual). Primary completion is estimated for Dec 2026, 25 months after the start.
Of 796 non-industry interventional studies with no phase under Atrial Fibrillation, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 59. This study's planned 25 months is below that.
Counting every sponsor, half of 1,051 studies reached it within 33 months; a quarter within 18 and three quarters within 54.
How these figures are worked out, and which studies are left out of them.
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Seoul St. Mary's Hospital