 Peri-procedural and device-related complications will be evaluated as significant if there is 1 a pericardial effusion requiring drainage, surgery, or pericardiocentesis, 2 a cardioembolic event during the procedure, 3 significant peri-procedural bleeding i.e., major vascular bleeding requiring surgical revision, or blood concentrate transfusion, 4 device embolization, or 5 a thrombus on the device with a consequent cardioembolic event. 