Efficacy of Early Rhythm Control Therapy in Patients With Subclinical Atrial Fibrillation
SubclincalAF
2 other identifiers
interventional
520
1 country
1
Brief Summary
The goal of this study to find out the efficacy of early rhythm therapy in patients with subclinical atrial fibrillation detected by Cardiac Electronic Implantable Devices. Early rhythm therapy includes antiarrhythmic drug, cardioversion, and catheter ablation. The general control group receives general management without the above atrial fibrillation rhythm control treatment. Researchers will compare early rhythm control groups to general control groups to see if early rhythm therapy works to reduce the atrial fibrillation burden by 50% or more, or decrease the incidence of clinical AF documentation. Participants will:
- Randomly allocated to two groups at a 1:1 ratio.
- Receive the treatment according to their assigned group.
- Visit the clinic once every three months for checkups and tests.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2024
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 2, 2024
CompletedFirst Submitted
Initial submission to the registry
November 23, 2025
CompletedFirst Posted
Study publicly available on registry
March 3, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2029
March 3, 2026
February 1, 2026
4 years
November 23, 2025
February 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Less than 50% reduction in atrial fibrillation(AF) burden or clinical AF documentation Incidence Rate (AF recurrence rate)
Recurrence is defined as * either a less than 50% reduction in AF burden or the detection/occurrence of clinical AF AF control (efficacy) is defined as * reduction in AF burden of 50% or more 10% difference in the recurrence rate between the two groups using a comparison of proportions. Kaplan-Meier survival analysis will be performed, and the Log-rank test will be used to compare the groups. A Cox proportional-hazards model will be performed, including the experimental group and the randomization stratification factor. The hazard ratio and its 95% confidence interval between the two groups will be presented. Statistical significance will be determined by a P-value of \< 0.05.
From enrollment to 1 year
side effects related to medication or other treatments
From enrollment to 1 year
Secondary Outcomes (6)
Atrial fibrillation effect on quality-of-life questionnaire score
From enrollment to 1 year
cardiovascular death, cerebral infarction, hospitalization due to heart failure aggravation
From enrollment to 1 year
NTproBNP(pg/ml)
From enrollment to 1year
Korean Montreal Cognitive Assessment (K-MoCA)
From enrollment to 1 year
Left ventricular ejection fraction(LVEF)
From enrollment to 1 year
- +1 more secondary outcomes
Study Arms (2)
early rhythm control group
EXPERIMENTALEarly rhythm control group receives atrial fibrillation rhythm control treatment based on guidelines. This includes antiarrhythmic treatment, cardioversion, and catheter ablation. Antiarrhythmic drugs include flecainide, propafenone, pilsicainide, sotalol, amiodarone, dronedarone and so on, and the doctor chooses the drug in consideration of structural heart disease, coronary artery disease, abnormal left ventricular hypertrophy, and heart failure.(Refer to the Korean Heart rhythm Society atrial Fibrillation Treatment Guidelines) Catheter ablation is a procedure that uses high-frequency energy to block the site of tachycardia in the heart. Cardioversion is a procedure that converts the electrical activity of the heart to sinus rhythm by directly giving electric shock on the surface of the heart. Catheter ablation or cardioversion is a treatment method performed only when clinical atrial fibrillation is confirmed.
general control group
ACTIVE COMPARATORThe general control group receives general management without the above atrial fibrillation rhythm control treatment.(Observation without additional medication, or heart rate control treatment if necessary) Heart rate control drugs such as beta-blockers, calcium channel blockers (Non-dihydropyridine CCB), and digoxin are used for heart rate control according to the doctor's prescription.
Interventions
flecainide, propafenone, pilsicainide, sotalol, amiodarone, dronedarone and so on
only when clinical atrial fibrillation (if atrial fibrillation continued for more than 30 seconds on a 12-lead electrocardiogram or holter monitoring) is confirmed
General management without atrial fibrillation rhythm control treatment.(Observation without additional medication, or heart rate control treatment if necessary) Heart rate control drugs such as beta-blockers, calcium channel blockers (Non-dihydropyridine CCB), and digoxin are used for heart rate control according to the doctor's prescription.
Eligibility Criteria
You may qualify if:
- Among patients with Cardiac implantable electronic device (CIED), subjects with atrial high rate episodes found Cardiac implantable electronic devices: implantable loop recorder, pacemaker, implantable cardioverter defibrillator(ICD), cardiac resynchronized therapy(CRT)
- Patients aged 19 or older who have agreed to the study (if voluntary consent is deemed difficult, consent from legal representatives is obtained together)
- If the accumulated period of the atrial high rate episode during the three-month observation period is more than 21 hours
- Patients whose atrial fibrillation has not been confirmed by electrocardiogram or holter monitoring within the past year from the time atrial high rate episode was detected
- However, enrollment is possible even if it includes one of the following two cases ⓐ Patients diagnosed and recorded as atrial fibrillation on medical records but not confirmed by electrocardiogram or holter monitoring
- ⓑ If there is a record of atrial fibrillation, but Paroxysmal AF less than 30 seconds
You may not qualify if:
- Patients deemed inappropriate to participate in the study by the investigator
- Patients diagnosed with atrial fibrillation with 12-lead electrocardiogram or holter within the past year prior to participation in the study
- Patients taking Class Ic, III of antiarrhythmic drugs prior to study participation
- Patients who have had rhythm control treatments such as Radiofequency catheter ablation (RFCA), Total thoracoscopic ablation (TTA), Maze procedure (MAZEop), and antiarrhythmic treatment due to atrial fibrillation (except for CTI ablation with AFL)
- Patients whose life expectancy is less than one year (e.g., patients who can't even have a heart transplant, patients who receive DNR, Patients in hospice wards who refuse life-sustaining treatment, terminal cancer patients who cannot receive radiation or chemotherapy, etc.)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Samsung Medical Centerlead
- Korea University Guro Hospitalcollaborator
- Korea University Anam Hospitalcollaborator
- Keimyung University Dongsan Medical Centercollaborator
- Sinchon Severance Hospital, Yonsei University College of Medicinecollaborator
- Wonju Severance Christian Hospitalcollaborator
- Asan Medical Centercollaborator
- Inje University Ilsan Paik Hospitalcollaborator
- The Catholic University of Koreacollaborator
Study Sites (1)
Samsung Medical Center
Seoul, Seoul, 06351, South Korea
Related Publications (3)
Sagris D, Georgiopoulos G, Pateras K, Perlepe K, Korompoki E, Milionis H, Tsiachris D, Chan C, Lip GYH, Ntaios G. Atrial High-Rate Episode Duration Thresholds and Thromboembolic Risk: A Systematic Review and Meta-Analysis. J Am Heart Assoc. 2021 Nov 16;10(22):e022487. doi: 10.1161/JAHA.121.022487. Epub 2021 Nov 10.
PMID: 34755543RESULTHindricks G, Potpara T, Dagres N, Arbelo E, Bax JJ, Blomstrom-Lundqvist C, Boriani G, Castella M, Dan GA, Dilaveris PE, Fauchier L, Filippatos G, Kalman JM, La Meir M, Lane DA, Lebeau JP, Lettino M, Lip GYH, Pinto FJ, Thomas GN, Valgimigli M, Van Gelder IC, Van Putte BP, Watkins CL; ESC Scientific Document Group. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS): The Task Force for the diagnosis and management of atrial fibrillation of the European Society of Cardiology (ESC) Developed with the special contribution of the European Heart Rhythm Association (EHRA) of the ESC. Eur Heart J. 2021 Feb 1;42(5):373-498. doi: 10.1093/eurheartj/ehaa612. No abstract available.
PMID: 32860505RESULTKirchhof P, Camm AJ, Goette A, Brandes A, Eckardt L, Elvan A, Fetsch T, van Gelder IC, Haase D, Haegeli LM, Hamann F, Heidbuchel H, Hindricks G, Kautzner J, Kuck KH, Mont L, Ng GA, Rekosz J, Schoen N, Schotten U, Suling A, Taggeselle J, Themistoclakis S, Vettorazzi E, Vardas P, Wegscheider K, Willems S, Crijns HJGM, Breithardt G; EAST-AFNET 4 Trial Investigators. Early Rhythm-Control Therapy in Patients with Atrial Fibrillation. N Engl J Med. 2020 Oct 1;383(14):1305-1316. doi: 10.1056/NEJMoa2019422. Epub 2020 Aug 29.
PMID: 32865375RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor
Study Record Dates
First Submitted
November 23, 2025
First Posted
March 3, 2026
Study Start
January 2, 2024
Primary Completion (Estimated)
December 15, 2027
Study Completion (Estimated)
December 31, 2029
Last Updated
March 3, 2026
Record last verified: 2026-02