Continued Access to PREVAIL (CAP2) - WATCHMAN Left Atrial Appendage (LAA) Closure Technology

Inclusion Criteria: A subject may be enrolled in the study if all of the following inclusion criteria are met:

• The subject is 18 years of age or older
• The subject has documented paroxysmal, persistent, or permanent non- valvular atrial fibrillation (i.e., the subject has not been diagnosed with rheumatic mitral valvular heart disease)
• The subject is eligible for long-term warfarin therapy
• The subject has a calculated CHADS2 score of 2 or greater; Subjects with a CHADS2 score of 1 may be included if any of the following apply (according to the ACC/AHA/ESC 2006 Guidelines for the Management of

Subjects with Atrial Fibrillation subjects requiring warfarin therapy):

• The subject is a female age 75 or older
• The subject has a baseline Left Ventricular Ejection Fraction (LVEF) > 30% and 50% stenosis with symptoms of ipsilateral transient or visual TIA evidenced by amaurosis fugax, ipsilateral hemispheric TIAs or ipsilateral stroke); if subject has a history of carotid stent or endarterectomy the subject is eligible if there is 110 bpm
• The subject has thrombocytopenia (defined as 2mm
• The subject has a high risk patent foramen ovale (PFO) with an atrial septal aneurysm excursion > 15mm or length > 15mm
• The subject has a high risk PFO with a large shunt defined as early, within 3 beats or substantial passage of bubbles
• The subject has significant mitral valve stenosis (i.e., MV <1.5 cm2)
• The subject has complex atheroma with mobile plaque of the descending aorta or aortic arch
• The subject has a cardiac tumor