An interventional study of early rhythm control group and cardioversion, catheter ablation in Atrial Fibrillation (AF), Diseases of the Circulatory System and Atrial Flutter, sponsored by Samsung Medical Center. Recruiting at 1 site in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-03-03.
Sponsored by Samsung Medical Center · Not applicable, Interventional, and Treatment
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:
There have been reports that early rhythm control therapy reduces various heart events in patients with atrial fibrillation. The definition of "early" atrial fibrillation defined in this study was defined as a patient within one year of diagnosis. This means clinical atrial fibrillation diagnosed by 12-lead electrocardiogram.
Atrial high rate episode (AHRE) may be found through various Cardiac Electronic Implantable Devices (CIED), which is defined as subclinical atrial fibrillation. There have been many studies on the risk of such subclinical atrial fibrillation causing cerebral infarction, and meta-analysis results show that there is a high risk of thromboembolism if there is an episode of 30 seconds or the sum of duration is more than 24 hours. However, there is no research on the rhythm control therapy for patients with subclinical atrial fibrillation, and this study might be considered as an important factor in determining the truly early atrial fibrillation treatment guideline. Therefore, this study aims to find out the efficacy of early rhythm therapy in patients with subclinical atrial fibrillation detected by Cardiac Electronic Implantable Devices.
This study is a randomized, multicenter, prospective, interventional study to observe the efficacy of early rhythm control treatment compared to general control treatment in patients with subclinical atrial fibrillation. According to the electronic random assignment program, it is divided into two groups (early rhythm control group, general control group) and allocated at a 1:1 ratio. This study is open-label study. Early rhythm control groups get rhythm control treatment for atrial fibrillation based on guidelines. This includes antiarrhythmic drug, cardioversion, and catheter ablation. The general control group receives general management (observation, heart rate control treatment if necessary) without the above atrial fibrillation rhythm control treatment. In both groups, appropriate anticoagulant treatment is given if there is an indication of cerebral infarction prevention associated with atrial fibrillation.
4,009 studies on the registry are indexed under Atrial Fibrillation; 961 are open to participants now.
This study's planned enrollment of 520 is above the median of 150 across 2,476 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Samsung Medical Center is the lead sponsor of 1,011 studies on the registry; 152 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
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
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.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Early 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.
Drug: early rhythm control group · Procedure: cardioversion, catheter ablation
The 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.
Other: general control
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.
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.
Time frame: From enrollment to 1 year
side effects related to medication or other treatments
Time frame: From enrollment to 1 year
Atrial fibrillation effect on quality-of-life questionnaire score
Atrial fibrillation effect on quality-of-life questionnaire scale 0 to 100 Score ranges from a minimum of 0 to a maximum of 100. A higher score indicates a worse outcome.
Time frame: From enrollment to 1 year
cardiovascular death, cerebral infarction, hospitalization due to heart failure aggravation
Individual events and composite events will be presented using frequencies and percentages. Cox proportional-hazards model will be performed, including the treatment group and the randomization stratification factor. The Log-rank test will be used to compare the incidence rates and hazard ratios between the experimental and active comparator groups.
Time frame: From enrollment to 1 year
NTproBNP(pg/ml)
Measured in pg/mL
Time frame: From enrollment to 1year
Korean Montreal Cognitive Assessment (K-MoCA)
Korean Montreal Cognitive Assessment (K-MoCA) score 0 to 30. Score ranges from a minimum of 0 to a maximum of 30, where higher scores indicate better cognitive performance.
Time frame: From enrollment to 1 year
Left ventricular ejection fraction(LVEF)
LVEF in percentage as measured by echocardiography
Time frame: From enrollment to 1 year
Diastolic function assessment
Calculate the E/e' ratio using the early diastolic filling velocity (E) and the early diastolic mitral annular velocity (e'), both measured in m/s.
Time frame: From enrollment to 1year
Plan to share: Undecided
Started Jan 2024 (actual). Primary completion is estimated for Dec 2027, 47 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 47 months is above 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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