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SINGLE SHOT CHAMPION clinical trial data summary banner

SINGLE SHOT CHAMPION clinical trial

About the study

The SINGLE SHOT CHAMPION trial was a randomized 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.

Superior Efficacy

Checkmark icon.

FARAPULSE treatment resulted in a significant reduction (13.6%) in atrial arrhythmia (AA) recurrence (p=0.046) vs Arctic Front Advance at 12 months

Study Design

Schematic showing the trial design 210 patients with symptomatic, drug refractory PAF were randomized 1:1 and underwent PVI with either PFA or CBA. Continuous rhythm monitoring with Reveal LINQ™
  • 210 patients with symptomatic, drug refractory PAF were randomized 1:1 and underwent PVI with either PFA or CBA.
  • Non-inferiority was assessed using a margin of 20% for the difference in cumulative incidence
  • Ablation effectiveness was assessed with continuous rhythm monitoring (Medtronic Reveal LINQ™).
  • No repeat ablations were allowed during the 3-month blanking period and AADs were discontinued after the blanking period.

Key findings

13.6%

FARAPULSE significantly reduced AA Recurrence

Line graph showing that FARAPULSE significantly reduced AA recurrence (62.9%) compared to Arctic Front Advance (49.4%)

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).

Line graph showing 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%). It also shows that at 12 months, inclusive of the blanking period (days 1-365), the recurrence-free rate for FARAPULSE was 55.2% and 37.0% for Arctic Front Advance

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 BSC

FARAPULSE™ Pulsed Field Ablation System indications, safety and warnings

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."