WATCHMAN Implantation During Hybrid Ablation

• Documented paroxysmal or (long-standing) persistent non-valvular atrial fibrillation,
• Eligible at least for short-term OAC therapy,
• No other conditions that would require long-term OAC therapy, suggested by current standard medical practice, and thus is eligible to stop OAC if the LAA is sealed,
• Calculated CHA2DS2-VASc score of 1 or more,
• 18 years of age or older, able and willing to provide written informed consent.

Exclusion Criteria:

• Current New York Heart Association Class IV Congestive Heart Failure,
• Current thrombocytopenia (\< 100x10E9/L) or anemia (hemoglobin \<6.2 mmol/L),
• Active infection or sepsis,
• Resting heart rate > 110 beats per minute,
• Cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the last 30 days,
• Recent myocardial infarction (within 3 months),
• Transient case of AF (i.e., secondary to recent cardiac surgery (within 3 months)),
• Planned cardioversion 30 days post implant of the WATCHMAN Device,
• Implanted mechanical valve prosthesis,
• History of obliterated LAA,
• History of heart transplantation,
• Symptomatic carotid disease (i.e., carotid stenosis >50% associated with ipsilateral transient or visual ischemic attack evidenced by amaurosis fugax, ipsilateral hemispheric TIAs or ipsilateral stroke within 6 months),
• Necessity to use long-term OAC,
• Contraindication for use of OAC or dual anti-platelet therapy,
• Contraindication for use of aspirin,
• Pregnancy or planned pregnancy during the course of the investigation,
• Life expectancy less than 2 years,
• Participation in any other clinical study involving an investigational drug or device.

Echocardiographic Exclusion Criteria (as assessed via transthoracic echocardiography (TTE) or TEE) for this study are:

• Left ventricular ejection fraction (LVEF) \< 30%,
• Intracardiac thrombus as visualized by TEE within 2 days prior to implant,
• High risk patent foramen ovale,
• Current atrial septal defect and/or previous atrial septal repair or closure device,
• Significant mitral valve stenosis (i.e., MV 4. 5 cm2),
• Existing pericardial effusion of >3 mm,
• Complex atheroma with mobile plaque of the descending aorta and/or aortic arch,
• Cardiac tumor.