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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
early rhythm control group
Drugflecainide, propafenone, pilsicainide, sotalol, amiodarone, dronedarone and so on
cardioversion, catheter ablation
Procedure/Surgeryonly when clinical atrial fibrillation (if atrial fibrillation continued for more than 30 seconds on a 12-lead electrocardiogram or holter monitoring) is confirmed
general control
Other interventionGeneral management without atrial fibrillation rhythm control treatment.(Observation without additional medication, or heart rate control treatment if necessary) Heart rate control drugs such as beta-blockers, calcium channel blockers (Non-dihydropyridine CCB), and digoxin are used for heart rate control according to the doctor's prescription.
Treatment groups
520 Participants
are divided into 2 treatment groupsGroup A: early rhythm control groupExperimental treatment 2 interventions
Group B: general control groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Less than 50% reduction in atrial fibrillation(AF) burden or clinical AF documentation Incidence Rate (AF recurrence rate)
Recurrence is defined as * either a less than 50% reduction in AF burden or the detection/occurrence of clinical AF AF control (efficacy) is defined as * reduction in AF burden of 50% or more 10% difference in the recurrence rate between the two groups using a comparison of proportions. Kaplan-Meier survival analysis will be performed, and the Log-rank test will be used to compare the groups. A Cox proportional-hazards model will be performed, including the experimental group and the randomization stratification factor. The hazard ratio and its 95% confidence interval between the two groups will be presented. Statistical significance will be determined by a P-value of \< 0.05.
Time frame
From enrollment to 1 year2
side effects related to medication or other treatments
Time frame
From enrollment to 1 yearSecondary outcomes
1
Atrial fibrillation effect on quality-of-life questionnaire score
Atrial fibrillation effect on quality-of-life questionnaire scale 0 to 100 Score ranges from a minimum of 0 to a maximum of 100. A higher score indicates a worse outcome.
Time frame
From enrollment to 1 year2
cardiovascular death, cerebral infarction, hospitalization due to heart failure aggravation
Individual events and composite events will be presented using frequencies and percentages. Cox proportional-hazards model will be performed, including the treatment group and the randomization stratification factor. The Log-rank test will be used to compare the incidence rates and hazard ratios between the experimental and active comparator groups.
Time frame
From enrollment to 1 year3
NTproBNP(pg/ml)
Measured in pg/mL
Time frame
From enrollment to 1year4
Korean Montreal Cognitive Assessment (K-MoCA)
Korean Montreal Cognitive Assessment (K-MoCA) score 0 to 30. Score ranges from a minimum of 0 to a maximum of 30, where higher scores indicate better cognitive performance.
Time frame
From enrollment to 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
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