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A Randomized Study Comparing the Efficacy and Safety of Catheter Ablation of Persistent Atrial Fibrillation between Cryoballoon and Radiofrequency Ablation (CRRF-PeAF study)

Efficacy and Safety of Cryoballoon and Radiofrequency Catheter Ablation of Persistent Atrial Fibrillation (CRRF-PeAF study)

Kusano Kengo

National Cerebral and Cardiovascular Center

6-1, Kishibeshinmachi, Suita, Osaka

kusanokengo@gmail.com

Miyamoto Koji

National Cerebral and Cardiovascular Center

6-1, Kishibeshinmachi, Suita, Osaka

+81-6-6170-1070

koji3koji3@gmail.com

Not Recruiting

April. 08, 2021

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

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

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

Both

persistent atrial fibrillation

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

atrial fibrillation, catheter ablation, radiofrequency, cryoballoon

catheter ablation

D001281

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)

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, left ventricular diameter, and left atrial diameter and volume (index) after 1 and 3 years of ablation treatment
3. creatinine clearance, BNP, CK, and CKMB levels at 1 and 3 years after ablation treatment (for CK and CKMB, 1-5 days after ablation treatment)
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

+81-6-6645-3456

Mar. 01, 2021

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