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The SINGLE SHOT CHAMPION trial was a randomised clinical trial published in the New England Journal of Medicine.1 It directly compared the safety and effectiveness of the FARAWAVE™ Pulse Field Ablation (PFA) catheter versus Medtronic Arctic Front Advance™ Cryoballoon (CBA) to treat symptomatic, drug refractory paroxysmal atrial fibrillation (PAF) with continuous rhythm monitoring.
FARAPULSETM treatment resulted in a significant reduction (13.6%) in atrial arrhythmia (AA) recurrence (p=0.046) vs Arctic Front Advance at 12 months
13.6%
FARAPULSE significantly reduced AA Recurrence
At 12 months, FARAPULSE demonstrated superiority in freedom from AA recurrence (62.9%) compared to Arctic Front Advance (49.4%), (p<0.001 for non-inferiority, p=0.046 for superiority).
There was a significant reduction in AA recurrence during the blanking period in patients treated with FARAPULSE (recurrence-free rate 61.9%) vs Arctic Front Advance (recurrence-free rate 41.9%), (95% CI, -33.2 to -6.8%). When the blanking period was included (days 1-365), there was an 18.2% reduction in atrial arrhythmia recurrence. The recurrence-free rate for FARAPULSE was 55.2% and 37.0% for Arctic Front Advance (95% CI< -31.5% to -4.9%).
SINGLE SHOT CHAMPION was supported by an unrestricted research grant from Boston Scientific
References
1. Reichlin, Tobias, et al. "Pulsed field or cryoballoon ablation for paroxysmal atrial fibrillation." New England Journal of Medicine 392.15 (2025): 1497-1507."
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