New findings from the SINGLE SHOT CHAMPION trial (NCT05534581), presented at EHRA 2025 and published in the New England Journal of Medicine, showed the FARAPULSE™ Pulsed Field Ablation (PFA) System to be superior in reducing atrial arrhythmia (AA) recurrence for treating symptomatic, drug-refractory paroxysmal atrial fibrillation (PAF) compared to the Artic Front Advance™ cardiac cryoablation catheter.
Key Findings:
- Superior efficacy: The FARAPULSE PFA System significantly reduced AA recurrence compared to Arctic Front Advance at 12 months (recurrence-free rate, 62.9% vs 49.3%, p<0.001 for non-inferiority, p=0.046 for superiority).
- Greater reduction in recurrence during the blanking period: There was an even greater reduction in AA recurrence during the blanking period, or the three-months post-ablation where the heart tissue is healing, (recurrence-free rate, 61.9% vs. 41.9%) resulting in a 20% reduction (95% CI, -33.2% to -6.8%).
- Parity on other measures: There were no significant differences in safety outcomes, clinical interventions, or quality of life measures between treatment groups.
Study Significance
This investigator-initiated clinical trial used continuous rhythm monitoring, providing a comprehensive and unbiased assessment of ablation efficacy. The results offer greater confidence in the FARAPULSE PFA System ability to improve outcomes for PAF patients.
Explore the full study to see study details, full data and explore the impact on clinical practice.
SINGLE SHOT CHAMPION was supported by an unrestricted research grant from BSC.
Reichlin, Tobias, et al. (in press). “Pulsed Field or Cryoballoon Ablation for Paroxysmal Atrial Fibrillation.” New England Journal of Medicine.
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