atrial fibrillation atrial fibrillation, catheter ablation, cryoballoon
Conditions
Interventions
cryoballoon ablation of asymptomatic atrial fibrillation
no cryoballoon ablation of asymptomatic atrial fibrillation
catheter ablation
Sponsors
Miyamoto Koji
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients aged 20-85 years old 2. Patients who atrial fibrillation was documented with 12-lead EGC within a year 3. Patients diagnosed as asymptomatic atrial fibrillation 4. Patients with written informed consent
Exclusion criteria
Exclusion criteria: 1. Patients with history of catheter ablation and/or surgery of atrial fibrillation 2. Patients with left atrial dimension more than 55 mm 3. Pregnant patients 4. Patients with concomittant participation in intervention study with other medication and/or medical instrument 5. Patients with active systemic infection 6. Patients with thrombus in the heart 7. Patients with cryoglobulinemia 8. Patients after stent implantation at pulmonary veins 9. Patients with LVEF <35% 10. Patients with heart failure of NYHA III or iV 11. Patients with any untreated or uncontrolled hyperthyroidism 12. Patients with any untreated or uncontrolled hypothyroidism 13. Patients with symptomatic carotid stenosis 14. Patients with unstable angina pectoris 15. Patients with myocardial infarction within 3 months proir to enrollment 16. Patients with any condition contraindicating chronic anticoagulation 17. Patients with myxoma 18. Patients with severe renaly dysfunction (eGFR <15ml/min) 19. Patients whom doctors responsible for this study judge inappropriate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of sinus rhythm 1 year after the study participation except for recurrence of atrial tachyarrhythmias during blanking period (within 90 days after study participation) | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy 1. Rate of sinus rhythm 6 months after study participation 2. Time to recurrence of atrial tachyarrhythmia 1 year after study participation 3. AF burden 6 months, 1 year after study participation 4. BNP 6 months, 1 year after study participation 5. Exercise tolerance 1 year after study participation 6. Cr, CCr, eGFR, cystation C 6 months, 1 year after study participation 7. LVEF, LAD, LAV 1 year after study participation 8. Cardiovascular events, all cause death, cardiovascular death 1 year after study participation 9. Success rate of PVI, total procedure time, LA dwelling time, fluoroscopy time, radiation dose 10. AFEQT 1 year after study participation 11. Relationship between atrial tachyarrhythmia recurrence and patient characteristics, examination results, and ablation procedure safety 1. Complication of catheter ablation 2. Adverse events | — |
Contacts
Public ContactKoji Miyamoto
National Cerebral and Cardiovascular Center
Outcome results
None listed