Stroke
Conditions
Keywords
Exclusion, Left Atrial Appendage, Surgical, Open chest
Brief summary
The dual primary safety and effectiveness outcomes for the use of The TigerPaw System include the rate of device related adverse and serious adverse events and the extent of complete exclusion of the LAA with minimal residual cavity.
Detailed description
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.
Interventions
DEVICELAAx TigerPaw System
Exclusion of Left Atrial Appendage
Sponsors
LAAx, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The dual primary safety and effectiveness outcomes include the rate of device related adverse and serious adverse events and the extent of complete exclusion of the LAA with minimal residual cavity. | Patients will be evaluated at 30 days post surgery and at 90 days post surgery. |
Secondary
| Measure | Time frame |
|---|---|
| The extent of complete exclusion of the LAA with minimal residual cavity. | 30 days post surgery and at 90 days post |
Countries
United States
Contacts
Primary ContactMichael A Daniel, MS/ MBA
Outcome results
None listed