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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by LAAx, Inc..
Recruitment status was  Recruiting
Sponsor:
Information provided by:
LAAx, Inc.
ClinicalTrials.gov Identifier:
NCT00962702
First received: August 19, 2009
Last updated: NA
Last verified: August 2009
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Stroke
Device: LAAx TigerPaw System
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Exclusion of the Left Atrial Appendage With the LAAx, Inc., TigerPaw™ System During Elective, Non-Endoscopic Cardiac Surgery Procedures

Further study details as provided by LAAx, Inc.:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The extent of complete exclusion of the LAA with minimal residual cavity. [ Time Frame: 30 days post surgery and at 90 days post ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: August 2009
Estimated Study Completion Date: October 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exclusion of Left Atrial Appendage
Exclusion of Left Atrial Appendage
Device: LAAx TigerPaw System
Exclusion of Left Atrial Appendage

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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00962702

Contacts
Contact: Michael A Daniel, MS/ MBA 4154070223 madaniel@clinregconsult.com

Locations
United States, Indiana
Clarian Health / Methodist Hospital Recruiting
Indianapolis, Indiana, United States
Principal Investigator: Arthur Coffee, MD         
Sponsors and Collaborators
LAAx, Inc.
Investigators
Principal Investigator: Mark Slaughter, MD University of Louisville
  More Information

No publications provided

Responsible Party: William Wheeler, CEO LAAx,Inc.
ClinicalTrials.gov Identifier: NCT00962702     History of Changes
Other Study ID Numbers: LAAx1DD20809
Study First Received: August 19, 2009
Last Updated: August 19, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by LAAx, Inc.:
Exclusion
Left Atrial Appendage
Surgical
Open chest

ClinicalTrials.gov processed this record on September 16, 2014