Cryoablation of Atrial Fibrillatio

Not Applicable

Recruiting

• Conditions: atrial fibrillation; atrial fibrillation, catheter ablation, cryoballoon; D001281

• Registration Number: JPRN-jRCTs052220038
• Lead Sponsor: Miyamoto Koji

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-06-06
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 60

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
efficacy<br>1. Rate of sinus rhythm 6 months after study participation<br>2. Time to recurrence of atrial tachyarrhythmia 1 year after study participation<br>3. AF burden 6 months, 1 year after study participation<br>4. BNP 6 months, 1 year after study participation<br>5. Exercise tolerance 1 year after study participation<br>6. Cr, CCr, eGFR, cystation C 6 months, 1 year after study participation<br>7. LVEF, LAD, LAV 1 year after study participation<br>8. Cardiovascular events, all cause death, cardiovascular death 1 year after study participation<br>9. Success rate of PVI, total procedure time, LA dwelling time, fluoroscopy time, radiation dose<br>10. AFEQT 1 year after study participation<br>11. Relationship between atrial tachyarrhythmia recurrence and patient characteristics, examination<br>results, and ablation procedure <br>safety<br>1. Complication of catheter ablation<br>2. Adverse events