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

JRCT ID: jRCT1052210003

Registered date:08/04/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: persistent atrial fibrillation
• Date of first enrollment: 13/04/2021
• Target sample size: 500
• Study type: Interventional

Intervention(s)

control group: radiofrequency catheter ablation of atrial fibrillation
intervention group: cryoballoon ablation of atrial fibrillation

Outcome(s)

• Primary Outcome: 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

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

Key inclusion & exclusion criteria

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

Include 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

Exclude 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

Related Information

• Primary Sponsor: Kusano Kengo