At this year’s European Heart Rhythm Association (EHRA) congress (30 March–1 April 2025, Vienna, Austria), a late-breaking presentation of data from the SINGLE SHOT CHAMPION study revealed the Farapulse pulsed field ablation (PFA) system (Boston Scientific) to be non-inferior—and potentially superior—to the Arctic Front Advance cardiac cryoablation catheter (Medtronic) in the treatment of symptomatic, drug-refractory paroxysmal atrial fibrillation (AF). Here, principal investigator Tobias Reichlin (Bern University Hospital, Bern, Switzerland), who shared these findings at EHRA 2025, speaks to Cardiac Rhythm News to discuss the data in more detail and outline their wider implications.
In your view, how significant is the primary endpoint finding of the SINGLE SHOT CHAMPION study?
It is very important for the field! It is the final proof that PFA, for sure and with no doubt, is non-inferior to thermal energies. But, for the first time, we also see this very strong and pretty clear signal for fewer recurrences with PFA.
Could you comment on the importance of the study’s finding of reduced AF recurrence with PFA versus cryoablation being maintained even after the blanking period was excluded?
Even though the superiority finding was borderline (p=0.046), it is the first time that an energy source performs better for the treatment of AF versus another—this was not the case for radiofrequency ablation (RFA) versus cryo in FIRE AND ICE (Kuck et al, New England Journal of Medicine, 2016) or CIRCA-DOSE (Andrade et al, Circulation, 2019). The magnitude of the treatment effect—13.6% in favour of PFA—was huge, so this is very important and big news for electrophysiology (EP).
The safety outcomes between the two study arms were generally similar but, in your opinion, were any of the safety-related findings particularly noteworthy or surprising?
No, the bottom line is that complications were very low in both groups, speaking to the safety of the procedure.
The study also found that PFA procedures were generally shorter compared to cryoablation. What is the significance of this when it comes to patient outcomes and real-world clinical practice?
The pulmonary vein isolation (PVI) procedures using this particular PFA device, Farapulse, are now highly standardised—regardless of the prior experience of the operator—due to a shorter learning curve for an easier procedure. This makes the outcomes more predictable for the patients and the lab schedules more predictable for the EP staff.
While the study’s primary endpoint was powered to detect non-inferiority, do you feel future research may seek to more thoroughly evaluate PFA’s potential superiority versus other modalities? If not, what shape do you think future studies involving PFA will take?
Given the magnitude of the treatment effect observed in our study, I think it is pretty clear that this particular PFA device (Farapulse) is superior to cryoballoon ablation. Given the differences to other PFA devices with regards to both device design and PFA waveform, the other PFA devices will need similar randomised trials comparing them to thermal energies in patients with paroxysmal AF, and they should also use implantable cardiac monitors (ICMs) for continuous rhythm monitoring, but with slightly larger sample sizes. Secondly, we will see ablation strategy trials with PFA in patients with persistent AF—such as PVI versus PVI plus posterior wall ablation (PWA), or PVI versus PVI plus lines, or PVI versus PVI plus scar ablation.
Overall, how strong do you feel these data are in establishing the role of PFA and the Farapulse system in today’s standard of care for AF?
The field has already significantly moved to PFA. Our data support this paradigm shift and do not provide reasons to move back to cryoablation. The Farapulse system is now quite clearly the dominant PFA system already, and the data indicate this is for a good reason. While this study is strong in supporting Farapulse, it will similarly promote—and be used to promote—other PFA systems as well.
More generally, where do you see the role for PFA alongside/as a replacement for other modalities like RFA and cryoablation in the treatment of AF over the next few years?
I think, with the combination of improved safety (mainly atrioesophageal [AE] fistula), enhanced procedural ease and efficiency, and now also better outcomes, PFA will largely replace the other energies for the treatment of AF in the next few years. In fact, I would be surprised if RFA and cryoablation would still play a relevant role for the treatment of AF five years from now.
Tobias Reichlin is the head of electrophysiology and a professor of medicine in the Department of Cardiology at Bern University Hospital (Bern, Switzerland).
Disclosures:
The investigator-initiated SINGLE SHOT CHAMPION trial was funded by the Inselspital (Bern University Hospital) and the Basel University Hospital, and supported by an unrestricted research grant from Boston Scientific, which was used to cover the cost of the implantable cardiac monitors.
Outside of the present study, Tobias Reichlin also reports the following disclosures: Research grants from the Swiss National Science Foundation, Swiss Heart Foundation, Sitem-Insel support funds, Biotronik, Boston Scientific and Medtronic; speaker/consulting honoraria or travel support from Abbott/St Jude Medical (SJM), Bayer, Biosense Webster (J&J), Biotronik, Boston Scientific, Farapulse, Medtronic, Pfizer/ Bristol-Myers Squibb (BMS); support for his institution’s fellowship programme from Abbott/SJM, Biosense Webster, Biotronik, Boston-Scientific and Medtronic.
