Omega™ Left Atrial Appendage (LAA) Occluder in Patients With Non-Valvular Atrial Fibrillation

Inclusion Criteria: 1. 60 years of age or older 2. Documented paroxysmal, persistent, or permanent non-valvular atrial fibrillation (AF) 3. At increased risk of stroke or systemic embolism defined as CHADS2 score \> 2 or a CHA2DS2-VASc score \> 3 4. Deemed, by investigator, to be unsuitable or contraindicated for long term oral anticoagulation therapy due to high bleeding risk 5. To have suitable anatomy for percutaneous LAA occlusion procedure with a single Omega™ device based on CT scan evaluation 6. Able and willing to comply with the required medication regimen post-device implant 7. Able to understand and willing to provide written informed consent to participate in the study 8. Able to and willing to return for required follow-up visits and examinations. Exclusion criteria: 1. Requires long-term oral anticoagulation therapy for any indication other than atrial fibrillation 2. Contraindicated for or allergic to aspirin, clopidogrel, warfarin or novel oral anticoagulant (NOAC) use 3. Has undergone surgical atrial septal defect (ASD) repair or has an ASD closure device implanted 4. Has undergone surgical patent foramen ovale (PFO) repair or has a PFO closure device implanted 5. Implanted with a mechanical heart valve prosthesis thus requiring long term oral anticoagulation 6. Has any contraindications for a percutaneous catheterization procedure (e.g. subject is too small to accommodate the transoesophageal echocardiogram (TEE/TOE) probe or required catheters, or subject has active infection or bleeding disorder) 7. Stroke or transient ischemic attack (TIA) within 90 days prior to implant procedure 8. Underwent any cardiac or non-cardiac intervention or surgery within 30 days prior to implant, or intervention or surgery is planned within 60 days after implant procedure 9. Myocardial infarction (MI) within 90 days prior to implant 10. New York Heart Association Class IV Congestive Heart Failure 11. Left ventricular ejection Fraction (LVEF) \<30% 12. Symptomatic carotid artery disease (defined as \>50% reduced diameter 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 \>50% reduced diameter 13. Reversible cause of AF (i.e. secondary thyroid disorders, acute alcohol intoxication, trauma, recent major surgical procedures) 14. History of idiopathic or recurrent venous thromboembolism requiring long term oral anticoagulation 15. Left atrial appendage is obliterated or surgically ligated 16. Resting heart rate \>110 bpm 17. Thrombocytopenia (defined as \< 70,000 platelets/mm3) or anaemia with haemoglobin concentration of \< 10 g/dl (i.e. anaemia as determined by the investigator which would require transfusion) 18. Actively enrolled or plans to enrol in a concurrent clinical study in which the active treatment arm may confound the results of this trial 19. Active endocarditis or other infection producing bacteraemia 20. Subject has a known malignancy or other illness where life expectancy is less than 2 years 21. Impaired renal function with eGFR \<40 ml/min/1.73 m2 22. More than mild hepatic failure, i.e. ALT, AST, or Alkalic Phosphatase \>2× upper limit of normal Echocardiographic Exclusion Criteria: 1. Intracardiac thrombus - including LAA - visualized by echocardiographic imaging 2. Existing circumferential pericardial effusion \>2mm 3. Significant mitral valve stenosis (i.e. mitral valve area \<1.5 cm2) 4. High risk patent foramen ovale (PFO), defined as an atrial septal aneurysm (atrial septal excursion \>15mm; excursion defined as maximal protrusion of the ASA beyond the plane of the atrial septum during cardiac cycle) or large shunt (substantial passage of bubbles, i.e. \>25, within 3 cardiac cycles from appearing in the right atrium) 5. Complex atheroma with mobile plaque of the descending aorta and/or aortic arch 6. Cardiac tumour 7. LAA anatomy cannot accommodate an Omega™ device (as per IFU) 8. Placement of the device would interfere with any intracardiac or intravascular structure.