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

Recruiting

Phase 2 Results N/A

Trial Description

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.

Conditions

Interventions

  • LAAx TigerPaw System Device
    Intervention Desc: Exclusion of Left Atrial Appendage
    ARM 1: Kind: Experimental
    Label: Exclusion of Left Atrial Appendage
    Description: Exclusion of Left Atrial Appendage

Trial Design

  • Allocation: Non-Randomized
  • Masking: Open Label
  • Purpose: Prevention
  • Endpoint: Safety/Efficacy Study
  • Intervention: Single Group Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary 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. Yes
Secondary The extent of complete exclusion of the LAA with minimal residual cavity. 30 days post surgery and at 90 days post Yes

Sponsors