Comparison of PolarX and the Arctic Front Cryoballoons for PVI in Patients With Symptomatic Paroxysmal AF
Status:
Recruiting
Trial end date:
2026-01-31
Target enrollment:
Participant gender:
Summary
Pulmonary vein isolation (PVI) is an effective treatment for atrial fibrillation (AF). Single
shot devices are increasingly used for PVI. Currently, Medtronic Arctic Front cryoballoon is
the most frequently used single shot technology and hence is the benchmark for upcoming
technologies. A novel cryoballoon technology has recently been introduced (PolarX, Boston
Scientific). However, whether PolarX provides effectiveness similar to the
standard-of-practice Medtronic Arctic Front cryoballoon is yet to be investigated. Given that
PolarX was developed considering the reported limitations and potential failures associated
with the Medtronic Arctic Front cryoballoon, it might be even more effective and safe for use
in AF ablation procedures.
The aim of this trial is to compare the efficacy and safety of the PolarX Cryoballoon (Boston
Scientific) and the Arctic Front Cryoballoon (Medtronic) in patients with symptomatic
paroxysmal AF undergoing their first PVI.
This is an investigator-initiated, multicenter, randomized controlled, open-label trial with
blinded endpoint adjudication. Given that the Medtronic Arctic Front Cryoballoon is the
standard-of-practice for single shot PVI and the PolarX is the novel technology, this trial
has a non-inferiority design.
The hypothesis with regards to the primary efficacy endpoint is that the PolarX Cryoballoon
(Boston Scientific) shows lower efficacy compared to the Arctic Front Cryoballoon (Medtronic)
and that therefore more episodes of first recurrence of any atrial arrhythmia between days 91
and 365 will be observed in patients with symptomatic paroxysmal AF undergoing their first
PVI. Hence the alternative hypothesis postulates that the PolarX Cryoballoon is non-inferior
to the Arctic Front Cryoballoon. Rejection of the null hypothesis is needed to conclude
non-inferiority.