Discussion:
The FROZEN AF study demonstrates the safety and effectiveness of the POLARx cryoballoon, the trial met effectiveness and safety endpoints in patients with drug-refractory paroxysmal atrial fibrillation, with a high 1-year recurrence free rate or 79.9% and 0% phrenic nerve palsy. Additionally, the FIT extension arm demonstrates the promise of the variable size cryoballoon, with 84% freedom from AF recurrence and a promising safety profile.