Atrial Fibrillation (AF), Atrial Flutter, Diseases of the Circulatory System
Conditions
Keywords
earl rhythm control, subclinical atrial fibrillation, antiarrhythmic drugs
Brief 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.
Detailed description
There have been reports that early rhythm control therapy reduces various heart events in patients with atrial fibrillation. The definition of "early" atrial fibrillation defined in this study was defined as a patient within one year of diagnosis. This means clinical atrial fibrillation diagnosed by 12-lead electrocardiogram. Atrial high rate episode (AHRE) may be found through various Cardiac Electronic Implantable Devices (CIED), which is defined as subclinical atrial fibrillation. There have been many studies on the risk of such subclinical atrial fibrillation causing cerebral infarction, and meta-analysis results show that there is a high risk of thromboembolism if there is an episode of 30 seconds or the sum of duration is more than 24 hours. However, there is no research on the rhythm control therapy for patients with subclinical atrial fibrillation, and this study might be considered as an important factor in determining the truly early atrial fibrillation treatment guideline. Therefore, this study aims to find out the efficacy of early rhythm therapy in patients with subclinical atrial fibrillation detected by Cardiac Electronic Implantable Devices. This study is a randomized, multicenter, prospective, interventional study to observe the efficacy of early rhythm control treatment compared to general control treatment in patients with subclinical atrial fibrillation. According to the electronic random assignment program, it is divided into two groups (early rhythm control group, general control group) and allocated at a 1:1 ratio. This study is open-label study. Early rhythm control groups get rhythm control treatment for atrial fibrillation based on guidelines. This includes antiarrhythmic drug, cardioversion, and catheter ablation. The general control group receives general management (observation, heart rate control treatment if necessary) without the above atrial fibrillation rhythm control treatment. In both groups, appropriate anticoagulant treatment is given if there is an indication of cerebral infarction prevention associated with atrial fibrillation.
Interventions
DRUGearly rhythm control group
flecainide, propafenone, pilsicainide, sotalol, amiodarone, dronedarone and so on
PROCEDUREcardioversion, catheter ablation
only when clinical atrial fibrillation (if atrial fibrillation continued for more than 30 seconds on a 12-lead electrocardiogram or holter monitoring) is confirmed
OTHERgeneral control
General 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.
Sponsors
Samsung Medical Center
Korea University Guro Hospital
Korea University Anam Hospital
Keimyung University Dongsan Medical Center
Sinchon Severance Hospital, Yonsei University College of Medicine
Wonju Severance Christian Hospital
Asan Medical Center
Inje University Ilsan Paik Hospital
The Catholic University of Korea
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Less than 50% reduction in atrial fibrillation(AF) burden or clinical AF documentation Incidence Rate (AF recurrence rate) | From enrollment to 1 year | 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. |
| side effects related to medication or other treatments | From enrollment to 1 year | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Atrial fibrillation effect on quality-of-life questionnaire score | From enrollment to 1 year | 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. |
| cardiovascular death, cerebral infarction, hospitalization due to heart failure aggravation | From enrollment to 1 year | 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. |
| NTproBNP(pg/ml) | From enrollment to 1year | Measured in pg/mL |
| Korean Montreal Cognitive Assessment (K-MoCA) | From enrollment to 1 year | 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. |
| Left ventricular ejection fraction(LVEF) | From enrollment to 1 year | LVEF in percentage as measured by echocardiography |
| Diastolic function assessment | From enrollment to 1year | Calculate the E/e' ratio using the early diastolic filling velocity (E) and the early diastolic mitral annular velocity (e'), both measured in m/s. |
Countries
South Korea
Contacts
CONTACTJu Youn Kim, Clinical assistant professor, MD, Ph.D
Outcome results
None listed