Status:
UNKNOWN
Exclusion of the Left Atrial Appendage (LAA) With the LAAx, Inc. TigerPaw System
Lead Sponsor:
LAAx, Inc.
Conditions:
Stroke
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
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 pe...
Eligibility Criteria
Inclusion
- Greater than or equal to 18 years of age
- 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)
- 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
- Ejection fraction \> 30%
- Absence of thrombus in LAA
- During open procedure, LAA anatomy is determined to be suitable for closure
- life expectancy of \> 1 year
- patient willingness to cooperate with follow-up tests
- Informed Consent
Exclusion
- Previous cardiac surgery
- Contraindication to Transesophageal Echocardiography (TEE)
- Thrombus in the LAA/LA
- NYHA Class IV heart failure symptoms
- Need for emergent cardiac surgery (e.g., cardiogenic shock)
- Creatinine \> 200 umol/L
- Current diagnosis of active systemic infection
- Renal failure requiring dialysis or hepatic failure
- A known drug and/or alcohol addiction
- 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
- Preoperative need for an intra-aortic balloon pump or intravenous inotropes
- Treatment with thoracic radiation
- Concurrent chemotherapy
- Long term treatment with steroids not including intermittent use of inhaled steroids for respiratory diseases
- Known connective tissue disorders
- Coagulation disorders
- Any active medical condition that would preclude the patient from completing the study or would result in an unreasonable risk
- Active participation in another clinical trial.
- 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
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2010
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00962702
Start Date
August 1 2009
End Date
October 1 2010
Last Update
August 20 2009
Active Locations (1)
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1
Clarian Health / Methodist Hospital
Indianapolis, Indiana, United States