Comparison of the PolarX and the Arctic Front cryoballoon for pulmonary vein isolation in patients with symptomatic paroxysmal atrial fibrillation (COMPARE CRYO) - Study protocol for a randomized controlled trial. ...

• Main Authors: Maurhofer, Jens, Kueffer, Thomas, Knecht, Sven, Madaffari, Antonio, Badertscher, Patrick, Seiler, Jens, Krisai, Philipp, Jufer, Corinne, Asatryan, Babken, Heg, Dik, Servatius, Helge, Tanner, Hildegard, Kühne, Michael, Roten, Laurent, Sticherling, Christian, Reichlin, Tobias
• Format: Article in Journal/Newspaper
• Language: unknown
• Published: Elsevier 2023
• Subjects: 610 Medicine & health; Arctic
• Online Access: https://dx.doi.org/10.48350/186392; https://boris.unibe.ch/186392/

INTRODUCTION Single-shot devices are increasingly used for pulmonary vein isolation (PVI) in atrial fibrillation (AF). The Arctic Front cryoballoon (Medtronic) is the most frequently used single-shot technology. A recently developed novel cryoballoon has been introduced (PolarX, Boston Scientific) with the aim to address limitations of the Arctic Front system. METHODS COMPARE CRYO is a multicentre, randomized, controlled trial with blinded endpoint adjudication by an independent clinical events committee. A total of 200 patients with paroxysmal AF undergoing their first PVI are randomized 1:1 between PolarX cryoballoon ablation and Arctic Front cryoballoon ablation. Continuous monitoring during follow-up is performed using an implantable cardiac monitor (ICM) in all patients. The primary endpoint is time to first recurrence of any atrial tachyarrhythmia (AF, atrial flutter, and/or atrial tachycardia) ≥ 120 s between days 91 and 365 post ablation as detected on the (ICM). Procedural safety is assessed by a ...