Actively Recruiting
Efficacy of Early Rhythm Control Therapy in Patients With Subclinical Atrial Fibrillation
Led by Samsung Medical Center · Updated on 2026-03-03
520
Participants Needed
1
Research Sites
106 weeks
Total Duration
On this page
Sponsors
S
Samsung Medical Center
Lead Sponsor
K
Korea University Guro Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of early rhythm control therapy in patients with subclinical atrial fibrillation detected by Cardiac Electronic Implantable Devices. This study aims to determine if early rhythm therapy, including antiarrhythmic drugs, cardioversion, and catheter ablation, reduces the burden of atrial fibrillation by 50 or more or lowers the incidence of clinical atrial fibrillation. The trial compares early rhythm control treatment to general management without specific rhythm control therapies in this patient population. The study randomly assigns participants into two groups an early rhythm control group and a general control group, with equal allocation. The early rhythm control group receives treatments such as antiarrhythmic drugslike flecainide, propafenone, pilsicainide, sotalol, amiodarone, and dronedaronechosen based on individual heart conditions. Cardioversion and catheter ablation are performed only if clinical atrial fibrillation is confirmed. The general control group undergoes general management, which may include observation or heart rate control medications such as beta-blockers, calcium channel blockers, or digoxin as needed. Both groups receive anticoagulant treatment if indicated to prevent cerebral infarction. Participants visit the clinic every three months for checkups and tests. Researchers will measure the reduction in atrial fibrillation burden, incidence of clinical atrial fibrillation, and any side effects related to treatments over one year. Secondary assessments include quality of life, cardiovascular events, cognitive function, heart function, and blood markers. Safety and treatment effects will be monitored throughout the study, which continues until 2029.
CONDITIONS
Brief Title
Efficacy of Early Rhythm Control Therapy in Patients With Subclinical Atrial Fibrillation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 19 years or older who agree to participate
- Have a cardiac implantable electronic device such as implantable loop recorder, pacemaker, implantable cardioverter defibrillator, or cardiac resynchronized therapy device
- Have atrial high rate episodes recorded by the device totaling more than 21 hours during a three-month observation period
- Have no confirmed atrial fibrillation diagnosis by electrocardiogram or Holter monitoring within the past year
- May include patients diagnosed as atrial fibrillation in medical records without electrocardiogram or Holter confirmation or with paroxysmal atrial fibrillation episodes less than 30 seconds
You will not qualify if you...
- Patients deemed inappropriate for the study by the investigator
- Patients diagnosed with atrial fibrillation confirmed by electrocardiogram or Holter within the past year
- Patients currently taking Class Ic or Class III antiarrhythmic drugs
- Patients who have had rhythm control treatments such as radiofrequency catheter ablation, thoracoscopic ablation, Maze procedure, or antiarrhythmic treatment for atrial fibrillation (except CTI ablation for atrial flutter)
- Patients with life expectancy less than one year, including those in hospice or with terminal illness unable to receive treatment or transplantation consideration, or those with Do Not Resuscitate orders
Research Team
J
Ju Youn Kim, Clinical assistant professor, MD, Ph.D
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