Use of a multi-electrode radiofrequency balloon catheter to achieve pulmonary vein isolation in patients with paroxysmal atrial fibrillation: 12-Month outcomes of the RADIANCE study.

Background: The RADIANCE first-in-man study evaluated acute (3-month) safety and design concept in terms of utility of a new multi-electrode radiofrequency (RF) balloon catheter (HELIOSTAR, Biosense Webster) to achieve pulmonary vein isolation (PVI). After study conclusion, a subset of patients was followed up to 12 months.

Methods: Patients with drug refractory paroxysmal atrial fibrillation were enrolled.