- Question
- Does cryoballoon ablation (using two different application durations) achieve efficacy similar to contact force-guided radiofrequency ablation in paroxysmal atrial fibrillation, as assessed by continuous rhythm monitoring?
- Design
- Multicenter, randomized, single-blinded, three-arm parallel-group trial of 346 patients. All patients received an implantable loop recorder and were followed for 12 months.
- Population
- Patients with drug-refractory paroxysmal atrial fibrillation who were candidates for catheter ablation with pulmonary vein isolation.
- Intervention
- Two cryoballoon ablation groups: 4-minute applications (Cryo-4, n=115) or 2-minute applications (Cryo-2, n=116), with an additional bonus application after rewarming once isolation was achieved.
- Control
- Irrigated contact force-guided radiofrequency ablation (CF-RF, n=115) with wide circumferential pulmonary vein isolation.
- Primary outcome
- Time to first documented recurrence of atrial tachyarrhythmia (atrial fibrillation, atrial flutter or atrial tachycardia), symptomatic or asymptomatic, between days 91 and 365 after ablation, or a repeat ablation procedure at any time.
- Results
- One-year freedom from atrial tachyarrhythmia was 53.9% with CF-RF, 52.2% with Cryo-4 and 51.7% with Cryo-2 (P=0.87). Freedom from symptomatic atrial tachyarrhythmia was 79.1%, 78.2% and 73.3%, respectively (P=0.26), and atrial fibrillation burden fell by a median of 99.3%, 99.9% and 98.4% (P=0.36).
- Safety
- Serious adverse events occurred in 3 patients (2.6%) with CF-RF, 6 (5.3%) with Cryo-4 and 7 (6.0%) with Cryo-2, with no significant difference (P=0.24). Radiofrequency had a longer procedure duration but shorter fluoroscopy exposure than the cryoballoon groups.
- Conclusion
- Contact force-guided radiofrequency and both cryoballoon regimens had equivalent one-year efficacy, with a marked reduction in atrial fibrillation burden in all groups even though about half had some recurrence.
- Why it matters
- It showed that the choice between cryoballoon and radiofrequency can rest on practical procedural factors and center experience rather than expected differences in efficacy, and that shortening cryoballoon applications does not compromise outcomes. Continuous monitoring also showed that arrhythmia recurrence and burden control are distinct measures of success.
Card generated automatically with AI from the abstract of the original publication and the trial registry; every figure was checked against those sources. It may contain errors: verify the data at the source before using it for clinical decisions.
Generated on October 18, 2026