Early rhythm control treatment for subclinical atrial fibrillation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, multicenter, prospective interventional study will assign adults with device-detected subclinical atrial fibrillation to early rhythm control or general management in a 1:1 ratio. Early rhythm control may include antiarrhythmic drugs, electrical cardioversion, or catheter ablation, while the control group receives usual care without those rhythm-control interventions. Participants will be followed with clinic visits every three months and device monitoring to compare whether early rhythm control reduces atrial fibrillation burden by at least 50% or lowers the incidence of clinically documented AF. Eligible subjects are adults with cardiac implantable electronic devices who had atrial high rate episodes totaling more than 21 hours during a three-month observation and no ECG-confirmed AF within the prior year.

Why it matters

Who can join: the full rules

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 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.)

Where it's running

• Samsung Medical Center
  Seoul, Seoul, South Korea Recruiting

Study contacts

• Study coordinator: Ju Youn Kim, Clinical assistant professor, MD, Ph.D
• Email: kzzoo921@gmail.com
• Phone: 82-2-3410-3419

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.