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

LAAx

Status and phase

Unknown

Phase 2

Conditions

Stroke

Treatments

Device: LAAx TigerPaw System

Study type

Interventional

Funder types

Industry

Identifiers

NCT00962702

LAAx1DD20809

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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