Efficacy of Early Rhythm Control Therapy in Patients With Subclinical Atrial Fibrillation (NCT07447297) | Clinical Trial Compass
RecruitingNot Applicable
Efficacy of Early Rhythm Control Therapy in Patients With Subclinical Atrial Fibrillation
South Korea520 participantsStarted 2024-01-02
Plain-language 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.
Who can participate
Age range
19 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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 thoracos…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Less than 50% reduction in atrial fibrillation(AF) burden or clinical AF documentation Incidence Rate (AF recurrence rate)
Timeframe: From enrollment to 1 year
2
side effects related to medication or other treatments
Timeframe: From enrollment to 1 year
Trial details
NCT IDNCT07447297
SponsorSamsung Medical Center
Sponsor typeOTHER
Study typeINTERVENTIONAL
Primary completion2027-12-15
Contact for this trial
Ju Youn Kim, Clinical assistant professor, MD, Ph.D