Clinical Trials Directory

Trials / Withdrawn

WithdrawnNCT02226133

Video-Assisted Left Atrial Appendage Exclusion Trial

A Clinical Trial to Evaluate Safety and Effectiveness of the LAAx,Inc., TigerPaw System II LAA Exclusion Device for the Exclusion of the Left Atrial Appendage Via Video-Assisted Thoracoscopic Surgery ("VATS")

Status
Withdrawn
Phase
N/A
Study type
Interventional
Enrollment
0 (actual)
Sponsor
LAAx, Inc. · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Exclusion of the LAA(Left Atrial Appendage) using the TigerPaw II System with VATS technique is safe and effective.

Detailed description

The objective of this confirmatory study is to demonstrate that the LAAx, Inc. TigerPaw® II System can be safely and effectively used to exclude the Left Atrial Appendage (LAA) during cardiac surgery utilizing thoracoscopic camera and light source and thus remove, from the cleared indication for use, the direct vision limitation.

Conditions

Interventions

TypeNameDescription
DEVICELAAx, Inc. TigerPaw® System IIExclusion of Left Atrial Appendage.

Timeline

Start date
2015-04-01
Primary completion
2015-09-01
Completion
2015-12-01
First posted
2014-08-27
Last updated
2015-05-05

Locations

4 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT02226133. Inclusion in this directory is not an endorsement.