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

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

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

Inclusion Criteria6

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

Exclusion Criteria5

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.)

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.