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.

Study Overview

• Status: Unknown
• Conditions: Stroke
• Intervention / Treatment: Device: LAAx TigerPaw System

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States
      • Recruiting
      • Clarian Health / Methodist Hospital
      • Principal Investigator: Arthur Coffee, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Exclusion of Left Atrial Appendage	Device: LAAx TigerPaw System; Exclusion of Left Atrial Appendage

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	Patients will be evaluated at 30 days post surgery and at 90 days post surgery.

Secondary Outcome Measures

Outcome Measure	Time Frame
The extent of complete exclusion of the LAA with minimal residual cavity.	30 days post surgery and at 90 days post

Collaborators and Investigators

• Sponsor: LAAx, Inc.
• Investigators: Principal Investigator: Mark Slaughter, MD, University of Louisville

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (ANTICIPATED): December 1, 2009
• Study Completion (ANTICIPATED): October 1, 2010

Study Registration Dates

• First Submitted: August 19, 2009
• First Submitted That Met QC Criteria: August 19, 2009
• First Posted (ESTIMATE): August 20, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): August 20, 2009
• Last Update Submitted That Met QC Criteria: August 19, 2009
• Last Verified: August 1, 2009

More Information

Terms related to this study

• Keywords: Left Atrial Appendage; Surgical; Exclusion; Open chest
• Other Study ID Numbers: LAAx1DD20809