Study of Left Atrial Appendage Closure in Patients With Atrial Fibrillation - III

Inclusion Criteria:

1. Aged ≥ 21 years

2. Diagnosed non-valvular atrial fibrillation

3. Current CHADS2 score > 2

4. Currently contraindicated to or intolerant of standard anticoagulation therapy (i.e.,
warfarin, dabigatran, apixaban, and rivaroxaban) due to at least one of the
following: history of bleeding or high risk of bleeding; labile INR level (While on
anticoagulation therapy, participant had INR results "out of therapeutic range" > 40%
of the time, over a minimum period of 2 months.); non-compliant, unwilling to take,
or anticoagulant failure (e.g., TIA or stroke while on anticoagulant therapy).

5. Life expectancy of at least 1 year

6. Willing and able to return and comply with scheduled follow up visits

7. Willing and able to provide written informed consent

Exclusion Criteria:

1. Prior cardiac surgery involving opening of pericardium (e.g., CABG, heart
transplantation, valve surgery)

2. Prosthetic heart valve or ring in any position

3. Current NYHA Class IV heart failure symptoms

4. Current right heart failure

5. Myocardial infarction within last 3 months

6. Unstable angina within last 3 months

7. Current cardiogenic shock or hemodynamic instability

8. Current symptomatic carotid disease

9. Need for an intra-aortic balloon pump or intravenous inotropes

10. Embolic stroke within the last 30 days

11. Transient ischemic attack (TIA) within the last 30 days

12. Current diagnosis of active systemic infection

13. eGFR < 60 mL/min/1.73m2 within last 3 months

14. Current renal failure requiring dialysis

15. ALT or AST level > 3 times upper level of normal, indicating hepatic failure. (NOTE:
normal range provided by local laboratory performing the measurement), based on most
recent pre-procedure assessment (within 30 days of study treatment)

16. Current clinical evidence of cirrhosis

17. Any history of thoracic radiation

18. Current use of long term treatment with steroids, not including intermittent use of
inhaled steroids for respiratory diseases

19. Diagnosed autoimmune disease known to be associated with pericarditis (i.e., specific
connective tissue disorders)

20. Any history of pericarditis

21. Pectus excavatum (clinically defined by treating physician)

22. Severe scoliosis

23. Thrombocytopenia (platelet count < 100 x 109/L) based on most recent pre-procedure
assessment (within 30 days of study treatment)

24. Anemia with hemoglobin concentration of < 10 g/dL based on most recent pre-procedure
assessment (within 30 days of study treatment)

25. Pregnancy or desire to get pregnant within next 12 months.

26. Current enrollment in an investigation or study of a cardiovascular device or
investigational drug that would interfere with this registry

27. Mental impairment or other conditions, which may not allow patient to understand the
nature, significance and scope of the study

28. Any other criteria, which would make the patient unsuitable to participate in this
study as determined by clinical site Principal Investigator (e.g., an uncontrolled
drug and/or alcohol addiction)