Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2025-12-25 @ 3:53 AM
NCT ID:
NCT00962702
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00962702
Study Brief:
Protocol Section:
NCT00962702