Exclusion of the LAA(Left Atrial Appendage) using the TigerPaw II System with VATS technique is safe and effective.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Exclusion of Left Atrial Appendage.
ValleyCare Health System-Pleasanton
Pleasanton, California, United States
UMD School of Medicine
Baltimore, Maryland, United States
Geisinger Heart Institute
Danville, Pennsylvania, United States
Lankenau MOB East
Wynnewood, Pennsylvania, United States
rate of device related adverse and serious adverse events
Time frame: 30 (plus or minus 7) days
Exclusion of the Left Atrial Appendage
Primary effectiveness will be measured by the percentage of patients with exclusion of the LAA assessed intraoperatively via endoscopic image and transesophageal echocardiography (TEE).
Time frame: 30 days
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