Pulsed Field or Cryoballoon Ablation for Paroxysmal Atrial Fibrillation.
Summary
In a randomized trial with continuous rhythm monitoring, PFA showed a lower 1-year atrial arrhythmia recurrence (37.1%) than cryoballoon (50.7%), meeting noninferiority and achieving marginal superiority, with low and comparable complication rates (1.0% vs 1.9%).
Key Findings
- Primary endpoint met for noninferiority with a −13.6 percentage-point difference in recurrence (P<0.001) and achieved superiority (P=0.046).
- Atrial arrhythmia recurrence: 37.1% (PFA) vs 50.7% (cryo) from day 91 to 365.
- Procedure-related complications were low and comparable (1.0% vs 1.9%).
Clinical Implications
For symptomatic paroxysmal AF, PFA is a compelling alternative to cryoballoon ablation with lower recurrence under continuous monitoring and similar safety; centers may prioritize PFA where available.
Why It Matters
Provides high-quality, head-to-head evidence that supports PFA as an effective and safe first-line energy source for PVI, likely accelerating adoption and guideline updates in EP.
Limitations
- Single-country trial with modest sample size (n=210) and 12-month horizon
- Noninferiority margin (20 percentage points) is relatively wide
Future Directions
Larger, multicountry trials in persistent AF, long-term lesion durability, and real-world safety profiling across diverse anatomies and comorbidities.
Study Information
- Study Type
- RCT
- Research Domain
- Treatment
- Evidence Level
- I - Randomized head-to-head trial with objective rhythm monitoring endpoints
- Study Design
- OTHER