Cryoablation of Atrial Fibrillation

JRCT ID: jRCTs052220038

Registered date:06/06/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: atrial fibrillation
• Date of first enrollment: 27/06/2022
• Target sample size: 60
• Study type: Interventional

Intervention(s)

cryoballoon ablation of asymptomatic atrial fibrillation
no cryoballoon ablation of asymptomatic atrial fibrillation

Outcome(s)

• Primary Outcome: 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

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 85age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Miyamoto Koji
• Source(s) of Monetary Support: Medtronic,Takeda Science Foundation,Suzuken Memorial Foundation