a. Primary adverse events included device- or procedure- related death, major vascular access complications or bleeding, myocardial infarction, pericarditis, heart block, permanent phrenic nerve paralysis, stroke, thromboembolism, transient ischemic attack, pulmonary edema, and vagal nerve injury/gastroparesis within 7 days of the index ablation procedure. PAEs also included cardiac tamponade/perforation occurring up to 30 days post-procedure, atrioesophageal fistula occurring up to 90 days postprocedure, and PV stenosis occurring anytime during the 12-month follow-up period. The protocol-defined performance goal was 12%.​