Atlas

AtriClip® Left Atrial Appendage Exclusion Concomitant to Structural Heart Procedures (ATLAS)

Atlas [NCT02701062]

Description:  Patients without a documented history of AF but who present with a CHA2DS2- VASc of => 3 and HASBLED of => 3 and will undergo a valve or CABG (structural heart) procedure with direct visual access to the LAA will be eligible to participate based upon the inclusion and exclusion criteria defined in this protocol. Up to 2000 patients will enroll at up to 20 sites and will be randomized 2:1 (2 with AtriClip to 1 anticoagulation therapy and without AtriClip). Subjects who do not develop Post-operative Atrial Fibrillation (POAF) will be followed for 30 days for safety, subjects who develop POAF will be followed for 365 days post index procedure. 

Device: AtriClip® Gillinov-Cosgrove™ LAA Exclusion Systems 

Drug: Anticoagulation Therapy (No AtriClip®)

Primary Investigator: Castillo-Sang

Drug/Device Information
Device: AtriClip® Gillinov-Cosgrove™ LAA Exclusion Systems
Drug: Anticoagulation Therapy (No AtriClip®)
Compare the impact of POAF (Post operative AF)
AtriClip Gillinov-Cosgrove LAA Exclusion Systems (AtriClip PRO, Flex, Long or Standard)
Randomized 2:1 to AtriClip vs no AtriClip
AtriCure, Inc.