Safety and Efficacy of Persistent Atrial Fibrillation Ablation With a Cryoballoon Technology

Primary outcomes

1. Effectiveness

   Time frame: 1 year follow-up

   Primary effectiveness failure is defined as the composite of any of the following occurrences:

   Failure to achieve acute procedural success at the index procedure (pulmonary vein isolation); More than one repeat procedure during the blanking period (within 90 days post-index procedure); Documented atrial fibrillation, or new onset of atrial flutter or atrial tachycardia event (≥ 30 seconds in duration or from a 10 second 12-lead ECG) Repeat procedure for atrial fibrillation, or new onset of atrial flutter or atrial tachycardia Electrical and/or pharmacological cardioversion

   • Prescribed a new antiarrhythmic drug not documented at baseline Prescribed a higher dose of antiarrhythmic drug documented at baseline

2. Safety of the procedure

   Time frame: The safety endpoint was evaluated at 7-days 30-days and 1-year follow-up

   Safety is defined as the composite of any of the following occurrences:

   Death Myocardial infarction Persistent gastroparesis/injury to vagus nerve Stroke/Transient ischemic attack Thromboembolism/ Air embolism Cardiac tamponade/perforation Pneumothorax Serious vascular access complications* Pulmonary edema/Heart Failure Ablation related atrioventricular block not attributable to medication effect or vasovagal reaction.

   Safety events (0-30 days post procedure) Symptomatic pericardial effusion Safety events (0-360 days post procedure) Atrial esophageal fistula Persistent Phrenic nerve injury Pulmonary Vein Stenosis

   • Including hematoma requiring intervention or prolongation of hospital stay, artero-venous fistulas or pseudoaneurysm.