PFA non-inferior to CBA in symptomatic paroxysmal atrial fibrillation

At 1 year, 62.9% of patients were atrial fibrillation (AF) recurrence-free after pulsed field ablation (PFA), compared with 49.3% treated by cryoballoon ablation (CBA). Besides the significant endpoint for non-inferiority, testing for superiority of PFA was also positive.

The investigator-initiated randomised SINGLE SHOT CHAMPION trial (NCT05534581) explored the 12-month non-inferiority and safety of a treatment with PFA compared with CBA for symptomatic paroxysmal atrial fibrillation (AF) [1]. Results were simultaneously published in the New England Journal of Medicine [2].

A total of 210 patients undergoing their first pulmonary vein isolation were randomised to an intervention with PFA (Farapulse™ pentaspline) or CBA (Medtronic™ Arctic Front). Prof. Tobias Reichlin (Inselspital, Bern, Switzerland) underlined that all operators were experienced in both procedural systems. Continuous rhythm monitoring during follow-up was ensured by implanting cardiac monitors after ablation. The primary endpoint was defined as the first recurrence of any atrial arrhythmia lasting ≥30 seconds, incorporating a blanking period of 90 days.

Patients had a mean age of 63.7 and about 30% were women. The average time since AF diagnosis varied between 2.4 and 3.0 years and the proportion of anti-arrhythmic drug usage between 21% and 23%. Procedure time and left atrial dwell time was significantly shorter in the PFA arm compared with the CBA arm (P<0.001) with 55 and 36 minutes versus 73 and 52 minutes, respectively.

“Using a blanking period of 90 days, freedom from recurrence occurred in the pulse field ablation group in 62.9% of the patients, as opposed to 49.3% in the cryoballoon group,” Prof. Reichlin revealed. There was a significant difference in cumulative incidence of -13.6 percentage points (95% CI -26.9% to -0.3%) that confirmed non-inferiority (P<0.001). “Subsequent superiority testing indicated that also superiority was met with a P-value of 0.046,” Prof. Reichlin added. Results for freedom of recurrence without using the blanking period was also significantly in favour of PFA: 61.9% vs 41.9% at day 90 (P<0.001). Overall, low numbers of procedural complications were observed in both study arms.

Limitations of the study mentioned by Prof. Reichlin included its modest sample size, borderline statistical significance for superiority testing, and findings being specific to the pentaspline PFA system. In summary, PFA was non-inferior to CBA for paroxysmal AF treatment and may offer advantages in procedural efficiency together with arrhythmia recurrence reduction. Prof. Reichlin proposed larger outcome trials to further investigate the superior efficacy of PFA in this setting.

1. Reichlin T, et al. Pulsed field ablation or cryoballoon ablation for paroxysmal atrial fibrillation - the SINGLE SHOT CHAMPION randomised clinical trial. Late-breaking science 3, EHRA 2025, 30 March-01 April, Vienna, Austria.
2. Reichlin T, et al. N Engl J Med. 2025 Mar 31.

Copyright ©2025 Medicom Medical Publishers



Posted on 6 May 20256 May 2025