NCT07641582

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
800

participants targeted

Target at P75+ for not_applicable

Timeline
13mo left

Started Nov 2024

Typical duration for not_applicable

Geographic Reach
1 country

5 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress60%
Nov 2024Jun 2027

Study Start

First participant enrolled

November 19, 2024

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 6, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 11, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

June 11, 2026

Status Verified

June 1, 2026

Enrollment Period

2.1 years

First QC Date

June 6, 2026

Last Update Submit

June 6, 2026

Conditions

Atrial Fibrillation (AF)

Keywords

Polygenic Risk ScoreAtrial Fibrillation ScreeningHandheld ECGSNP ArrayHolter MonitoringGenetic Risk

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 year

Secondary Outcomes (2)

  • Incidence of newly diagnosed atrial flutter

    1 year

  • Predictive performance of the AF prediction model

    1 year

Study Arms (1)

AF Risk Group

EXPERIMENTAL

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 monitorDevice: Six-lead handheld electrocardiogram deviceGenetic: SNP array genotyping

Interventions

7-day continuous ECG patch monitorDEVICE

Continuous ECG patch worn for 7 days at enrollment to detect atrial fibrillation and other arrhythmias.

AF Risk Group
Six-lead handheld electrocardiogram deviceDEVICE

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
AF Risk Group
SNP array genotypingGENETIC

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.

AF Risk Group

Eligibility Criteria

Age20 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with symptoms suggestive of paroxysmal atrial fibrillation, such as intermittent palpitations or chest discomfort
  • Asymptomatic patients aged 60 or older with at least one of the following risk factors for atrial fibrillation: hypertension, diabetes, coronary artery disease, valvular heart disease, cardiomyopathy, sleep apnea, hyperthyroidism, obesity (BMI greater than 30), or chronic alcohol dependence (drinking more than 3 times per week)

You may not qualify if:

  • Age under 20 years or over 80 years
  • Moderate or severe cognitive impairment
  • Previously diagnosed with atrial fibrillation prior to study enrollment
  • Does not consent to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

The Catholic University of Korea Incheon St. Mary's Hospital

Incheon, South Korea

RECRUITING

The Catholic University of Korea Seoul St. Mary's Hospital

Seoul, 06591, South Korea

RECRUITING

The Catholic University of Korea Eunpyeong St. Mary's Hospital

Seoul, South Korea

RECRUITING

The Catholic University of Korea St. Vincent's Hospital

Suwon, South Korea

RECRUITING

The Catholic University of Korea Uijeongbu St. Mary's Hospital

Uijeongbu-si, South Korea

RECRUITING

Related Publications (5)

  • Yang L, Feng H, Ai S, Liu Y, Lei B, Chen J, Tan X, Benedict C, Wang N, Wing YK, Qi L, Zhang J. Association of accelerometer-derived circadian abnormalities and genetic risk with incidence of atrial fibrillation. NPJ Digit Med. 2023 Mar 4;6(1):31. doi: 10.1038/s41746-023-00781-3.

    PMID: 36869222BACKGROUND

  • Steinhubl SR, Waalen J, Edwards AM, Ariniello LM, Mehta RR, Ebner GS, Carter C, Baca-Motes K, Felicione E, Sarich T, Topol EJ. Effect of a Home-Based Wearable Continuous ECG Monitoring Patch on Detection of Undiagnosed Atrial Fibrillation: The mSToPS Randomized Clinical Trial. JAMA. 2018 Jul 10;320(2):146-155. doi: 10.1001/jama.2018.8102.

    PMID: 29998336BACKGROUND

  • Roselli C, Chaffin MD, Weng LC, Aeschbacher S, Ahlberg G, Albert CM, Almgren P, Alonso A, Anderson CD, Aragam KG, Arking DE, Barnard J, Bartz TM, Benjamin EJ, Bihlmeyer NA, Bis JC, Bloom HL, Boerwinkle E, Bottinger EB, Brody JA, Calkins H, Campbell A, Cappola TP, Carlquist J, Chasman DI, Chen LY, Chen YI, Choi EK, Choi SH, Christophersen IE, Chung MK, Cole JW, Conen D, Cook J, Crijns HJ, Cutler MJ, Damrauer SM, Daniels BR, Darbar D, Delgado G, Denny JC, Dichgans M, Dorr M, Dudink EA, Dudley SC, Esa N, Esko T, Eskola M, Fatkin D, Felix SB, Ford I, Franco OH, Geelhoed B, Grewal RP, Gudnason V, Guo X, Gupta N, Gustafsson S, Gutmann R, Hamsten A, Harris TB, Hayward C, Heckbert SR, Hernesniemi J, Hocking LJ, Hofman A, Horimoto ARVR, Huang J, Huang PL, Huffman J, Ingelsson E, Ipek EG, Ito K, Jimenez-Conde J, Johnson R, Jukema JW, Kaab S, Kahonen M, Kamatani Y, Kane JP, Kastrati A, Kathiresan S, Katschnig-Winter P, Kavousi M, Kessler T, Kietselaer BL, Kirchhof P, Kleber ME, Knight S, Krieger JE, Kubo M, Launer LJ, Laurikka J, Lehtimaki T, Leineweber K, Lemaitre RN, Li M, Lim HE, Lin HJ, Lin H, Lind L, Lindgren CM, Lokki ML, London B, Loos RJF, Low SK, Lu Y, Lyytikainen LP, Macfarlane PW, Magnusson PK, Mahajan A, Malik R, Mansur AJ, Marcus GM, Margolin L, Margulies KB, Marz W, McManus DD, Melander O, Mohanty S, Montgomery JA, Morley MP, Morris AP, Muller-Nurasyid M, Natale A, Nazarian S, Neumann B, Newton-Cheh C, Niemeijer MN, Nikus K, Nilsson P, Noordam R, Oellers H, Olesen MS, Orho-Melander M, Padmanabhan S, Pak HN, Pare G, Pedersen NL, Pera J, Pereira A, Porteous D, Psaty BM, Pulit SL, Pullinger CR, Rader DJ, Refsgaard L, Ribases M, Ridker PM, Rienstra M, Risch L, Roden DM, Rosand J, Rosenberg MA, Rost N, Rotter JI, Saba S, Sandhu RK, Schnabel RB, Schramm K, Schunkert H, Schurman C, Scott SA, Seppala I, Shaffer C, Shah S, Shalaby AA, Shim J, Shoemaker MB, Siland JE, Sinisalo J, Sinner MF, Slowik A, Smith AV, Smith BH, Smith JG, Smith JD, Smith NL, Soliman EZ, Sotoodehnia N, Stricker BH, Sun A, Sun H, Svendsen JH, Tanaka T, Tanriverdi K, Taylor KD, Teder-Laving M, Teumer A, Theriault S, Trompet S, Tucker NR, Tveit A, Uitterlinden AG, Van Der Harst P, Van Gelder IC, Van Wagoner DR, Verweij N, Vlachopoulou E, Volker U, Wang B, Weeke PE, Weijs B, Weiss R, Weiss S, Wells QS, Wiggins KL, Wong JA, Woo D, Worrall BB, Yang PS, Yao J, Yoneda ZT, Zeller T, Zeng L, Lubitz SA, Lunetta KL, Ellinor PT. Multi-ethnic genome-wide association study for atrial fibrillation. Nat Genet. 2018 Jun 11;50(9):1225-1233. doi: 10.1038/s41588-018-0133-9.

    PMID: 29892015BACKGROUND

  • Weng LC, Choi SH, Klarin D, Smith JG, Loh PR, Chaffin M, Roselli C, Hulme OL, Lunetta KL, Dupuis J, Benjamin EJ, Newton-Cheh C, Kathiresan S, Ellinor PT, Lubitz SA. Heritability of Atrial Fibrillation. Circ Cardiovasc Genet. 2017 Dec;10(6):e001838. doi: 10.1161/CIRCGENETICS.117.001838.

    PMID: 29237688BACKGROUND

  • US Preventive Services Task Force; Davidson KW, Barry MJ, Mangione CM, Cabana M, Caughey AB, Davis EM, Donahue KE, Doubeni CA, Epling JW Jr, Kubik M, Li L, Ogedegbe G, Pbert L, Silverstein M, Stevermer J, Tseng CW, Wong JB. Screening for Atrial Fibrillation: US Preventive Services Task Force Recommendation Statement. JAMA. 2022 Jan 25;327(4):360-367. doi: 10.1001/jama.2021.23732.

    PMID: 35076659BACKGROUND

MeSH Terms

Conditions

Atrial FibrillationGenetic Risk Score

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsGenetic Predisposition to DiseaseDisease SusceptibilityDisease Attributes

Study Officials

  • Young Choi, MD, PhD

    The Catholic University of Korea

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Young Choi, MD, PhD

CONTACT

82-2-1588-1511superstar@catholic.ac.kr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 6, 2026

First Posted

June 11, 2026

Study Start

November 19, 2024

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

June 30, 2027

Last Updated

June 11, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

KR(5)