Exclusion of the Left Atrial Appendage (LAA) With the LAAx, Inc. TigerPaw System

The primary safety outcome is the rate of device related adverse and serious adverse events
assessed peri-operatively, and at 30 and 90 days post procedure. The primary effectiveness
outcome is the percentage of patients with complete exclusion of the left atrial appendage
assessed peri-operatively (visually), and at 90 days post procedure via transesophageal
echocardiography (TEE).

Transesophageal echocardiography will be performed intra-operatively and again at 90 days
post procedure. Intra-operative and follow-up TEE examinations will be read centrally at a
core laboratory. Any Doppler flow across the Fastener into the excluded portion of the
appendage will also be considered a failure of exclusion. The presence or absence of LAA
and/or LA thrombus will be evaluated. Patients will also be evaluated for other potential
sources of embolism, including aortic atheroma, patent foramen ovale, or other intracardiac
shunts.

Data collection will be completed at baseline, at the time of open cardiac surgery procedure
and throughout the perioperative hospitalization. Patients will be evaluated at 30 days post
surgery and at 90 days post surgery.

Inclusion Criteria:

1. Greater than or equal to 18 years of age

2. Stroke Risk (CHADS score > or = 2, CHADS scoring: CHF = 1 pt, Hypertension (or treated
hypertension) = 1 pt, Age > 75 = 1 pt, Diabetes = 1 pt, Prior stroke or TIA = 2 pts)

3. Subject scheduled to undergo elective non-endoscopic cardiac surgical procedure(s)
including cardiac surgery for one or more of the following:

- mitral valve repair or replacement

- aortic valve repair or replacement

- tricuspid valve repair or replacement

- coronary artery bypass procedures

- concomitant surgical (ablation or cut and sew) Maze procedure

4. Ejection fraction > 30%

5. Absence of thrombus in LAA

6. During open procedure, LAA anatomy is determined to be suitable for closure

7. life expectancy of > 1 year

8. patient willingness to cooperate with follow-up tests

9. Informed Consent

Exclusion Criteria:

1. Previous cardiac surgery

2. Contraindication to Transesophageal Echocardiography (TEE)

3. Thrombus in the LAA/LA

4. NYHA Class IV heart failure symptoms

5. Need for emergent cardiac surgery (e.g., cardiogenic shock)

6. Creatinine > 200 umol/L

7. Current diagnosis of active systemic infection

8. Renal failure requiring dialysis or hepatic failure

9. A known drug and/or alcohol addiction

10. 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

11. Preoperative need for an intra-aortic balloon pump or intravenous inotropes

12. Treatment with thoracic radiation

13. Concurrent chemotherapy

14. Long term treatment with steroids not including intermittent use of inhaled steroids
for respiratory diseases

15. Known connective tissue disorders

16. Coagulation disorders

17. Any active medical condition that would preclude the patient from completing the study
or would result in an unreasonable risk

18. Active participation in another clinical trial.

19. Intraoperative:

- LAA is not appropriate for exclusion based upon intraoperative evaluations

- Presence of thrombus in LAA or LA; or

- Any other findings by surgeon/investigator that would preclude use of device