Kenneth A Ellenbogen, Suneet Mittal, Niraj Varma, Arash Aryana, Nassir Marrouche, Ante Anić, Devi Nair, Jean Champagne, Saverio Iacopino, Carlo de Asmundis, Stanislav Weiner, Kevin Makati, Jonathan D Raybuck, Elizabeth Richards, Wilber Su
INTRODUCTION: Cryoablation therapy for pulmonary vein isolation (PVI) to treat paroxysmal atrial fibrillation (PAF) is well established. A novel 28 mm cryoballoon system designed to operate under low pressure to safely reach a lower nadir temperature and maintain constant balloon size during cooling has not been prospectively studied in a large patient population for safety and efficacy. The FROZEN AF (NCT04133168) trial was an international multicenter, open-label, prospective, single-arm study on the safety and performance of a novel cryoballoon system for treatment of PAF...
March 6, 2024: Journal of Cardiovascular Electrophysiology