Evaluation of Safety and Performance of the Omega™ LAA (Left Atrial Appendage) Occluder and Omega™ Delivery System in Patients With Non-Valvular Atrial Fibrillation and High Bleeding Risk

Omega™ LAA (Left Atrial Appendage) Occluder used in combination with the indicated Omega™ Delivery System is a permanent implant to the left atrial appendage for percutaneous insertion. LLA (Left Atrial Appendage) occlusion appears to be a feasible option for stroke reduction in AF patients at high risk for stroke, who are contraindicated for anticoagulation or who suffered a stroke despite OC. This study will evaluate safety and performance, using a study design which is based on inputs from pre-clinical testing, the risk analysis and data available from other LAA (Left Atrial Appendage) devices.

Inclusion criteria

• 18 years of age or older
• Documented paroxysmal, persistent, or permanent non-valvular atrial fibrillation (AF)
• At increased risk of stroke or systemic embolism defined as a CHA2DS2-VASc score > or = 2
• To have suitable anatomy for percutaneous Left Atrial Appendage occlusion procedure with a single Omega™ device
• Able and willing to comply with the required medication regimen post-device implant
• Able to understand and willing to provide written informed consent to participate in the study

Exclusion criteria

• Requires long-term oral anticoagulation therapy for any indication other than atrial fibrillation
• Contraindicated for or allergic to aspirin, clopidogrel, warfarin or novel oral anticoagulant (NOAC) use
• 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)
• Women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment per physician discretion)
• Stroke or transient ischemic attack (TIA) within 6 weeks prior to implant procedure
• Myocardial infarction (MI) within 90 days prior to implant
• New York Heart Association Class IV Congestive Heart Failure
• Left ventricular ejection Fraction (LVEF) < or = 30%
• Left atrial appendage is obliterated or surgically ligated
• Actively enrolled or plans to enrol in a concurrent clinical study in which the active treatment arm may confound the results of this trial
• Active endocarditis or other infection producing bacteraemia
• Subject has a known malignancy or other illness where life expectancy is less than 2 years
• Impaired renal function with eGFR <30 ml/min/1.73 m2

Echocardiographic Exclusion Criteria:

• Intracardiac thrombus - including LAA - visualized by echocardiographic imaging
• Significant mitral valve stenosis (i.e. mitral valve area <1.5 cm2)
• Cardiac tumour
• LAA anatomy cannot accommodate an Omega™ device (as per IFU)
• Placement of the device would interfere with any intracardiac or intravascular structure.