NCT07447297

Efficacy of Early Rhythm Control Therapy in Patients With Subclinical Atrial Fibrillation

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 520 (estimated)
• Sponsor: Samsung Medical Center · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Atrial Fibrillation (AF)
• Diseases of the Circulatory System
• Atrial Flutter

Interventions

Type	Name	Description
DRUG	early rhythm control group	flecainide, propafenone, pilsicainide, sotalol, amiodarone, dronedarone and so on
PROCEDURE	cardioversion, catheter ablation	only when clinical atrial fibrillation (if atrial fibrillation continued for more than 30 seconds on a 12-lead electrocardiogram or holter monitoring) is confirmed
OTHER	general control	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.

Timeline

• Start date: 2024-01-02
• Primary completion: 2027-12-15
• Completion: 2029-12-31
• First posted: 2026-03-03
• Last updated: 2026-03-03

Locations

1 site across 1 country: South Korea