Heart Diseases
Conditions
Brief summary
Exclusion of the LAA(Left Atrial Appendage) using the TigerPaw II System with VATS technique is safe and effective.
Detailed description
The objective of this confirmatory study is to demonstrate that the LAAx, Inc. TigerPaw® II System can be safely and effectively used to exclude the Left Atrial Appendage (LAA) during cardiac surgery utilizing thoracoscopic camera and light source and thus remove, from the cleared indication for use, the direct vision limitation.
Interventions
DEVICELAAx, Inc. TigerPaw® System II
Exclusion of Left Atrial Appendage.
Sponsors
LAAx, Inc.
Study design
Allocation
NA
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. Capable and willing to give informed consent; 3. Able and willing to complete a 30 day ± 7 day follow-up evaluation; 4. Ejection fraction ≥ 30%; 5. Life expectancy of \> 1 year; 6. Stroke Risk (CHADS score of ≥ 1), CHADS scoring: CHF=1 point, Hypertension (or treated hypertension) = 1 point, Age \> 75 = 1 point, Diabetes = 1 point, Prior stroke or TIA = 2 points; 7. Subjects suitable for elective Video-Assisted Thoracoscopic Surgical (VATS) procedure(s) including, but not limited to, cardiac surgery for one or more of the following: 1. mitral valve repair or replacement, 2. aortic valve repair or replacement, 3. tricuspid valve repair or replacement, 4. coronary artery bypass procedures, 5. concomitant surgical (ablation or cut and sew) Maze procedure and other ablation procedures 6. hybrid procedures including combination surgical and interventional procedures and surgical procedures with a combination of left and right thoracic access sites
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| rate of device related adverse and serious adverse events | 30 (plus or minus 7) days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Exclusion of the Left Atrial Appendage | 30 days | Primary effectiveness will be measured by the percentage of patients with exclusion of the LAA assessed intraoperatively via endoscopic image and transesophageal echocardiography (TEE). |
Countries
United States
Outcome results
None listed