SINGLE SHOT CHAMPION
Trial question
Is pulsed field ablation noninferior to cryoballoon ablation in patients with symptomatic paroxysmal AF?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
28.0% female
72.0% male
N = 210
210 patients (59 female, 151 male).
Inclusion criteria: adult patients with symptomatic paroxysmal AF.
Key exclusion criteria: previous LA ablation or surgery; AF due to reversible causes; severe MR; LVEF < 35%; NYHA class III or IV HF.
Interventions
N=105 pulsed field ablation (pulmonary vein isolation using a pulsed field ablation system [Farapulse™]).
N=105 cryoballoon ablation (pulmonary vein isolation using cryoballoon [Arctic Front™]).
Primary outcome
Rate of recurrence of atrial tachyarrhythmia between days 91 to 365 after ablation
37.1%
50.7%
50.7 %
38.0 %
25.4 %
12.7 %
0.0 %
Pulsed field
ablation
Cryoballoon
ablation
Difference not exceeding
non-inferiority
margin ✓
Difference not exceeding non-inferiority margin in the rate of recurrence of atrial tachyarrhythmia between days 91 to 365 after ablation (37.1% vs. 50.7%; ARD -13.6, 95% CI -26.9 to -0.3).
Secondary outcomes
Significant decrease in the rate of recurrence of atrial tachyarrhythmia between days 1 to 90 after ablation (38.1% vs. 58.1%; ARD -20, 95% CI -33.2 to -6.8).
No significant difference in the rate of mean atrial arrhythmia burden during days 91 to 365 (1.4% vs. 1.9%; ARD -0.5, 95% CI -1.4 to 0.4).
No significant difference in hospitalization or emergency-department visit for atrial arrhythmia (1.9% vs. 7.6%; RR 0.25, 95% CI 0.05 to 1.15).
Safety outcomes
No significant difference in procedure-related complications within 30 days.
Conclusion
In adult patients with symptomatic paroxysmal AF, pulsed field ablation was noninferior to cryoballoon ablation with respect to the rate of recurrence of atrial tachyarrhythmia between days 91 to 365 after ablation.
Reference
Tobias Reichlin, Thomas Kueffer, Patrick Badertscher et al. Pulsed Field or Cryoballoon Ablation for Paroxysmal Atrial Fibrillation. N Engl J Med. 2025 Apr 17;392(15):1497-1507.
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