Efficacy of early rhythm control therapy in patients with subclinical atrial fibrillatio
- Conditions
- Diseases of the circulatory system
- Registration Number
- KCT0009027
- Lead Sponsor
- Samsung Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 520
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)
1) Patients aged 19 or older who have agreed to the study (if voluntary consent is deemed difficult, consent from legal representatives is obtained together)
2) If the accumulated period of the atrial high rate episode during the three-month observation period is more than 24 hours
3) 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
1) Patients deemed inappropriate to participate in the study by the investigator
2) Patients diagnosed with atrial fibrillation with 12-lead electrocardiogram or holter within the past year prior to participation in the study
3) Patients taking Class Ic, III of antiarrhythmic drugs prior to study participation
4) 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)
5) 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.)
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method decrease in atrial fibrillation burden by less than 50% or incidence of clinical AF documentation;side effects related to medication or other treatments
- Secondary Outcome Measures
Name Time Method cardiovascular death, cerebral infarction, hospitalization due to heart failure aggravation;Left ventricular function change, BNP change, AFEQT (quality of life assessment), MoCA (cognitive function assessment)