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

Phase 2

• Conditions: Stroke
• Interventions: Device: LAAx TigerPaw System

• Registration Number: NCT00962702
• Lead Sponsor: LAAx, Inc.

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 LAA with minimal residual cavity.

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 Timeline

• Status Verified: 2009-08
• Study Start: 2009-08
• Study First Submitted: 2009-08-19
• Study First Submitted QC: 2009-08-19
• Last Update Submitted: 2009-08-19
• Study First Posted: 2009-08-20
• Last Update Posted: 2009-08-20
• Primary Completion: 2009-12
• Study Completion: 2010-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Exclusion of Left Atrial Appendage	LAAx TigerPaw System	Exclusion of Left Atrial Appendage

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Clarian Health / Methodist Hospital; 🇺🇸 Indianapolis, Indiana, United States