Arrhythmias & electrophysiologyRandomised controlled trial
Pulsed Field or Cryoballoon Ablation for Paroxysmal Atrial Fibrillation
- Randomised controlled trial
- non-inferiority
Authors' conclusion
Among patients with symptomatic paroxysmal atrial fibrillation, PFA was noninferior to cryoballoon ablation with respect to the incidence of a first recurrence of atrial tachyarrhythmia, as assessed by continuous rhythm monitoring.
Study context
- Population
- Patients with symptomatic paroxysmal AF, Switzerland; all with an implantable cardiac monitor
- Participants
- 105 vs 105
- Comparison
- Pulsed field ablation (PFA) vs cryoballoon ablation
- PFAn = 105
- Cryoablationn = 105reference
- Primary endpoint
- First recurrence of atrial tachyarrhythmia (continuous rhythm monitoring)
- Follow-up
- Day 91 to day 365 after ablation
Primary result
As reported in the abstract
Between-group difference
−13.6 percentage points
95% CI −26.9 to −0.3
P < 0.001
Events by treatment group
PFA vs Cryoablation
between-group difference −13.6 percentage points (95% CI −26.9 to −0.3); P < 0.001
Non-inferiority margin 20 as printed, not drawn
Safety
Procedure-related complications (composite)
Original publication
Pulsed Field or Cryoballoon Ablation for Paroxysmal Atrial Fibrillation. N Engl J Med. Published 31 March 2025. doi:10.1056/nejmoa2502280
Summarised from the published abstract; every number is checked against it