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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2009 by LAAx, Inc..
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00962702
First Posted: August 20, 2009
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
LAAx, Inc.
August 19, 2009
August 20, 2009
October 12, 2017
August 2009
December 2009   (Final data collection date for primary outcome measure)
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. [ Time Frame: Patients will be evaluated at 30 days post surgery and at 90 days post surgery. ]
Same as current
No Changes Posted
The extent of complete exclusion of the LAA with minimal residual cavity. [ Time Frame: 30 days post surgery and at 90 days post ]
Same as current
Not Provided
Not Provided
 
Exclusion of the Left Atrial Appendage (LAA) With the LAAx, Inc. TigerPaw System
Exclusion of the Left Atrial Appendage With the LAAx, Inc., TigerPaw™ System During Elective, Non-Endoscopic Cardiac Surgery Procedures
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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Stroke
Device: LAAx TigerPaw System
Exclusion of Left Atrial Appendage
Experimental: Exclusion of Left Atrial Appendage
Exclusion of Left Atrial Appendage
Intervention: Device: LAAx TigerPaw System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
60
October 2010
December 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00962702
LAAx1DD20809
No
Not Provided
Not Provided
William Wheeler, CEO LAAx,Inc.
LAAx, Inc.
Not Provided
Principal Investigator: Mark Slaughter, MD University of Louisville
LAAx, Inc.
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP