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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1052210003

Enrollment

500

Registered

2021-04-08

Start date

2021-04-13

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

persistent atrial fibrillation atrial fibrillation, catheter ablation, radiofrequency, cryoballoon

Interventions

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

catheter ablation

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Measure

Time frame

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

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Contacts

Public ContactKoji Miyamoto

National Cerebral and Cardiovascular Center

koji3koji3@gmail.com+81-6-6170-1070

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026