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

Status unconfirmed · Phase 2

Conditions studied: Stroke

In brief

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.

Key facts

Study ID

NCT00962702

Run by

LAAx, Inc.

People needed

60

Starts

2009-08-01

Expected to finish

2010-10-01

Last updated by the study team

2009-08-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Clarian Health / Methodist Hospital — Indianapolis, Indiana, United States (enrolling)

Full record on ClinicalTrials.gov

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