Can the Lambre Device Occlude IRRegular And Large Appendages in Patients With Non-Valvular AF

Exclusion Criteria

• •1. Pregnant or nursing patients and those who plan pregnancy in the period up to 1 year following index procedure. Female patients of childbearing potential must have a negative pregnancy test done within 7 days prior to index procedure per site standard test
• •2. Patients with atrial fibrillation that is defined by a single occurrence, or that is transient or reversible (e.g., secondary to CABG, an interventional procedure, pneumonia, or hyperthyroidism)
• •3. Patients who require long-term anticoagulation/DAPT for a condition other than atrial fibrillation
• •4. Patients not suitable for short term oral anti-coagulation (including due to bleeding diathesis or coagulopathy or absolute contraindication to OAC or DAPT ) or who will refuse transfusion
• •5. Patients with rheumatic mitral valve disease, known severe aortic stenosis requiring surgical or percutaneous valve replacement, or existing mechanical valve prosthesis
• •6. Active infection with bacteremia
• •7. Known hypersensitivity or contraindication to aspirin, clopidogrel, heparin/bivalirudin, any device material or component (nitinol, nickel, titanium, PET), and/or contrast sensitivity that cannot be adequately pre-medicated
• •8. Anatomic conditions that would prevent performance of the LAA occlusion procedure (e.g., prior atrial septal defect \[ASD\] or patient foramen ovale \[PFO\] surgical repair or implanted closure device, or obliterated left atrial appendage)
• •9. Recent (within 30 days pre-procedure) or planned (within 60 days post procedure) cardiac or non-cardiac interventional or surgical procedure (e.g., cardioversion, ablation, percutaneous coronary intervention, cataract surgery, etc.)
• •10. Recent (within 90 days pre-procedure) stroke, transient ischemic attack, or myocardial infarction
• •11. Severe heart failure (New York Heart Association Class IV)
• •12. Known asymptomatic carotid artery disease with\>70% diameter stenosis OR symptomatic carotid disease (\>50% diameter stenosis with ipsilateral stroke or TIA). Subjects with prior carotid endarterectomy or carotid stent placement may be enrolled, provided that known diameter stenosis is \<50%.
• •13. Past or pending heart or any other organ transplant, or on the waiting list for any organ transplant
• •14. Current participation in another investigational drug or device study
• •15. Size of the left atrial appendage at the LAmbre Plus defined landing zone within outside the manufactures recommendations (Table 2.)
• •16. Patients with an indication for chronic P2Y12 platelet inhibition therapy
• •17. Patients who are unable to undergo CT scan
• •1. Left atrial appendage anatomy may accommodate implantation of the WATCHMAN device, according to IFU by size.
• •2. LVEF \<25%
• •3. Intracardiac thrombus or dense spontaneous echo contrast, as visualized by TEE within 2 days prior to implant
• •4. Presence of a high-risk patent foramen ovale (PFO), defined as an atrial septal aneurysm (excursion \>15 mm or length \>15 mm) or large shunt (early, within 3 beats and/or substantial passage of bubbles)
• •5. Moderate or severe mitral valve stenosis (mitral valve area \<1.5 cm2)
• •6. Complex atheroma with mobile plaque of the descending aorta and/or aortic arch (Grade 4 or higher)
• •7. Presence of an intracardiac tumor