Comparing 28 mm and 31 mm Balloon Cryoablation for Pulmonary Vein Isolation in Atrial Fibrillation Treatment

What this Trial Is About

Researchers are comparing two methods of pulmonary vein isolation PVI in patients with paroxysmal or persistent atrial fibrillation AF. The study evaluates whether using a larger 31 mm cryoablation balloon for extended antral isolation is superior to the standard 28 mm balloon for antral isolation in reducing atrial tachyarrhythmia recurrence and arrhythmic load over one year. This trial addresses the impact of larger ablation devices on heart function and arrhythmia outcomes. Participants receive PVI using either a 28 mm or a 31 mm cryoballoon catheter, both delivering cryoenergy to isolate pulmonary veins. The 28 mm balloon targets antral isolation, while the 31 mm balloon aims for extended antral isolation near the carina, resembling a wide ablation technique. The study is randomized and double-blinded, comparing these two single-shot ablation strategies in a controlled setting. During the study, patients are monitored for recurrence of atrial tachyarrhythmias lasting more than 30 seconds and overall arrhythmic burden up to 12 months post-procedure. Effectiveness is assessed through procedure times averaging 180 minutes and safety is tracked throughout the study duration. Researchers collect detailed arrhythmia load measurements during episodes and follow participants for adverse events and long-term outcomes, with study participation lasting at least one year.

Wide-Antral Pulmonary Vein Isolation in Atrial Fibrillation Ablation with a Single-shot Technique (WIDER-PVI)