Efficacy and Safety of Cryoballoon and Radiofrequency Catheter Ablation of Persistent Atrial Fibrillatio

Phase 4

Recruiting

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

• Registration Number: JPRN-jRCT1052210003
• Lead Sponsor: Kusano Kengo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-04-08
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

1. aged 20-85 years old
2. diagnosed as persistent atrial fibrillation
3. can be treated with either radiofrequency or cryoballoon and planned catheter ablation of atrial fi
brillation
4. written informed consent

Exclusion Criteria

1. history of catheter ablation and/or surgery of atrial fibrillation
2. atrial fibrillation lasting more than 1 year
3. left atrial dimension more than 50 mm
4. pregnant
5. concomittant participation in intervention study with other medication and/or medical instrument
6. patients whom doctors responsible for this study judge inappropriate

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
recurrence free rate of atrial tachyarrhythmia (atrial fibrillation, atrial flutter, atrial tachycardia) 1 year after catheter ablation except for blanking period (within 90 days after ablation)

Secondary Outcome Measures

Name	Time	Method
efficacy<br>1. recurrence free rate of atrial tachyarrhythmia (atrial fibrillation, atrial flutter, atrial tachycardia) 3 years after catheter ablation except for blanking period<br>2. left ventricular ejection fraction 1 and 3 years after ablation<br>3. Cr and BNP 1 and 3 years after ablation<br>4. cardiovascular event 1 and 3 years after ablation<br>5. all cause death and cardiovascular related death 1 and 3 years after ablation<br>6. symptom 1 and 3 years after ablation<br>7. acute success of pulmonary vein isolation, total procedure time, left atrium dwelling time, fluorosc<br>opy time, exposure dose, contrast medium dose, infusion volume<br>8. when additional ablation to pulmonary vein isolation performed, its frequency, type, recurrence fr<br>ee rate of atrial tachyarrhythmia 1 and 3 years after catheter ablation except for blanking period<br>safety<br>1. complication of catheter ablation