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

Prospective, Single-arm Study to Assess the Safety and Performance of the Omega™ Left Atrial Appendage (LAA) Occluder in Patients With Non-Valvular Atrial Fibrillation and High Bleeding Risk

The purpose of the study is to assess the safety and performance of the Omega™ LAA (Left Atrial Appendage) Occluder and Omega™ Delivery System in LAA (Left Atrial Appendage) closure for patients with non-valvular atrial fibrillation (NVAF) 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:

1. 18 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 a CHA2DS2-VASc score > or = 2
4. To have suitable anatomy for percutaneous Left Atrial Appendage occlusion procedure with a single Omega™ device
5. Able and willing to comply with the required medication regimen post-device implant
6. Able to understand and willing to provide written informed consent to participate in the study

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 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)
4. Women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment per physician discretion)
5. Stroke or transient ischemic attack (TIA) within 6 weeks prior to implant procedure
6. Myocardial infarction (MI) within 90 days prior to implant
7. New York Heart Association Class IV Congestive Heart Failure
8. Left ventricular ejection Fraction (LVEF) < or = 30%
9. Left atrial appendage is obliterated or surgically ligated
10. Actively enrolled or plans to enrol in a concurrent clinical study in which the active treatment arm may confound the results of this trial
11. Active endocarditis or other infection producing bacteraemia
12. Subject has a known malignancy or other illness where life expectancy is less than 2 years
13. Impaired renal function with eGFR <30 ml/min/1.73 m2

Echocardiographic Exclusion Criteria:

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