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
312 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
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.
CONDITIONS
Official Title
Efficacy of Early Rhythm Control Therapy in Patients With Subclinical Atrial Fibrillation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with cardiac implantable electronic devices (implantable loop recorder, pacemaker, ICD, CRT) showing atrial high rate episodes
- Patients aged 19 years or older who agree to participate (or have consent from legal representatives if necessary)
- Atrial high rate episodes totaling more than 21 hours during a three-month observation period
- No confirmed atrial fibrillation by electrocardiogram or Holter monitoring within the past year from detection of atrial high rate episode
- Enrollment allowed if diagnosed as atrial fibrillation in medical records but not confirmed by electrocardiogram or Holter monitoring
- Enrollment allowed if recorded paroxysmal atrial fibrillation episodes are less than 30 seconds
You will not qualify if you...
- Patients judged unsuitable for participation by the investigator
- Patients diagnosed with atrial fibrillation by electrocardiogram or Holter monitoring within the past year
- Patients currently taking Class Ic or III antiarrhythmic drugs
- Patients who have previously undergone rhythm control treatments such as radiofrequency catheter ablation, total thoracoscopic ablation, Maze procedure, or antiarrhythmic treatment for atrial fibrillation (except CTI ablation for atrial flutter)
- Patients with life expectancy less than one year (e.g., those in hospice care, refusing life-sustaining treatment, with terminal cancer, or ineligible for heart transplant)
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Trial Site Locations
Total: 1 location
1
Samsung Medical Center
Seoul, Seoul, South Korea, 06351
Actively Recruiting
Research Team
J
Ju Youn Kim, Clinical assistant professor, MD, Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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