Comparison of PolarX and the Arctic Front Cryoballoons for PVI in Patients With Symptomatic Paroxysmal AF
| Condition | Paroxysmal Atrial Fibrillation |
|---|---|
| Phase | Phase 4 |
| Sponsor | Insel Gruppe AG, University Hospital Bern |
| Status | Completed |
| Enrollment | 202 participants |
| Interventions | PVI using the Arctic Front Cryoballoon (Medtronic), PVI using the PolarX Cryoballoon (Boston Scientific) |
| Start date | Mar 29, 2021 |
| Completion date | Jul 31, 2023 |
| Results posted | Jul 24, 2026 |
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 P
Number of Patients With Recurrence of Any Atrial Tachyarrhythmia
| PVI Using the Arctic Front Cryoballoon (Medtronic) | 48 Participants |
|---|---|
| PVI Using the PolarX Cryoballoon (Boston Scientific) | 41 Participants |
Open in BENITIONS View on ClinicalTrials.gov
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