RecruitingNot ApplicableNCT07447297

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


Sponsor

Samsung Medical Center

Enrollment

520 participants

Start Date

Jan 2, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying whether treating atrial fibrillation early — before it is confirmed by a standard ECG — can reduce the risk of stroke and other complications. The study focuses on patients whose implanted heart devices (like pacemakers or defibrillators) have detected abnormally fast atrial rhythms, which may be an early sign of atrial fibrillation. **You may be eligible if:** - You have an implanted cardiac device (pacemaker, defibrillator, loop recorder, or CRT device) that has detected high-rate atrial episodes - You are 19 years of age or older - Over a 3-month monitoring period, the total time of these fast atrial episodes adds up to more than 21 hours - Your atrial fibrillation has not been confirmed by a standard ECG or Holter monitor in the past year **You may NOT be eligible if:** - Your atrial fibrillation has already been confirmed by an ECG or Holter monitor in the past year - You are already taking certain heart rhythm medications (Class Ic or III antiarrhythmic drugs) - You have had rhythm control procedures like catheter ablation or surgical maze procedures previously Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGearly rhythm control group

flecainide, propafenone, pilsicainide, sotalol, amiodarone, dronedarone and so on

PROCEDUREcardioversion, 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

OTHERgeneral 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.


Locations(1)

Samsung Medical Center

Seoul, Seoul, South Korea

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NCT07447297


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