New findings from the SINGLE SHOT CHAMPION trial, presented at the ongoing European Heart Rhythm Association (EHRA) congress (30 March–1 April 2025, Vienna, Austria) by Tobias Reichlin (Bern University Hospital, Bern, Switzerland), have shown the Farapulse pulsed field ablation (PFA) system (Boston Scientific) to be superior to the Arctic Front Advance cardiac cryoablation catheter (Medtronic) for treating symptomatic, drug-refractory paroxysmal atrial fibrillation (AF).
In the trial—the findings of which have also been published in the New England Journal of Medicine—the Farapulse PFA system significantly reduced atrial arrhythmia recurrence compared to Arctic Front Advance at 12 months, as per recurrence-free rates of 62.9% versus 49.3%, respectively (p<0.001 for non-inferiority; p=0.046 for superiority).
Farapulse also demonstrated an even greater reduction in recurrence during the study’s blanking period—the three-month post-ablation timeframe in which the heart tissue is healing. On this front, a Boston Scientific press release details a 20% reduction, relaying recurrence-free rates of 61.9% with Farapulse compared to 41.9% with Arctic Front Advance (95% confidence interval [CI]; -33.2% to -6.8%).
The release goes on to report parity regarding several other factors, as the SINGLE SHOT CHAMPION study found that there were no significant differences in safety outcomes, clinical interventions or quality-of-life measures between the two treatment groups—both of which included a total of 105 patients.
This investigator-initiated clinical trial used continuous rhythm monitoring, providing a “comprehensive and unbiased” assessment of ablation efficacy, and generating results that offer greater confidence in the Farapulse PFA system’s ability to improve outcomes for paroxysmal AF patients, according to Boston Scientific.
