Video-Assisted Left Atrial Appendage Exclusion Trial

Exclusion Criteria

• •1. Previous cardiac surgery;
• •2. Active systemic or cutaneous infection or inflammation;
• •3. Pre-existing immunodeficiency disorder and/or chronic use of systemic steroids not including intermittent use of inhaled steroids for respiratory diseases;
• •4. Known, significant history of bleeding diathesis, coagulopathy, von Willebrand's disease or current platelet count \< 100,000 cells/mm3, baseline INR ≥1.8, or fibrinogen level less than 150 mg/dl (if received a fibrinolytic agent within prior 24 hours);
• •5. Severe co-existing morbidities having a life expectancy of less than 1 year;
• •6. Currently involved in any other investigational clinical trials that have not completed their primary endpoint or that may interfere with the TigerPaw study results;
• •7. Thrombus in the LAA/LA;
• •8. NYHA Class IV heart failure symptoms;
• •9. Mental impairment or other conditions which may not allow the subject to understand the nature, significance and scope of the study and to cooperate with follow-up requirements;
• •10. Preoperative need for an intra-aortic balloon pump;
• •11. Significant anemia with a hemoglobin level less than 10 g/dL or a hematocrit less than 30%;
• •12. Females who are pregnant, planning to become pregnant within 1 month of the procedure, or lactating;
• •13. Extreme morbid obesity (BMI greater than 45 kg/m2);
• •14. Any active medical condition that would preclude the patient from completing the study or would result in an unreasonable risk;
• •15. Contraindication to Transesophageal Echocardiography (TEE);
• •16. Need for emergent cardiac surgery (e.g., cardiogenic shock);
• •17. Creatinine \>200 umol/L;
• •18. Renal failure requiring dialysis or hepatic failure;
• •19. A known drug and/or alcohol addiction;
• •20. Concurrent chemotherapy.