Efficacy of Early Rhythm Control Therapy in Patients With Subclinical Atrial Fibrillation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorSamsung Medical Center
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- early rhythm control group
- cardioversion, catheter ablation
- general control
Treatment groups
520 Participants
are divided into 2 treatment groupsSponsors and collaborators
Samsung Medical Center
Lead sponsor
Korea University Guro Hospital
Collaborator
Korea University Anam Hospital
Collaborator
Keimyung University Dongsan Medical Center
Collaborator
Sinchon Severance Hospital, Yonsei University College of Medicine
Collaborator
Wonju Severance Christian Hospital
Collaborator
Asan Medical Center
Collaborator
Inje University Ilsan Paik Hospital
Collaborator
The Catholic University of Korea
Collaborator
Source ClinicalTrials.gov