AtriCure Exclusion of the LAA in Patients Undergoing Concomitant Cardiac Surgery

Inclusion Criteria

• Subject is greater than or equal to 18 years of age.
• Subject has any one of the following risk factors and is thought to benefit from LAA occlusion:
• CHADS score > 2
• Age > 75 years
• Hypertension and age > 65 years
• Previous stroke
• History of atrial fibrillation (any classification)
• Subject is 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 placement, Tricuspid valve repair or replacement, Coronary artery bypass procedures, concomitant surgical (ablation or cut-and-sew) Maze procedure, patent foramen ovale (PFO), atrial septal defect (ASD) repair with the device deployed while on or prepared for cardio-pulmonary bypass support.
• Subject is willing and able to provide written informed consent.
• Subject has a life expectancy of at least 1 year.
• Subject is willing and able to return for scheduled follow-up visits.

Exclusion Criteria

• Previous cardiac surgery
• Thrombus in the LAA/LA which cannot be evacuated prior to placement of the Clip.
• Patients requiring surgery other than CABG and/or cardiac valve and/or surgical maze procedure and/or PFO closure and/or ASD repair.
• NYHA Class IV heart failure symptoms
• Need for emergent cardiac surgery (i.e. cardiogenic shock)
• Creatinine >200 µmol/L
• LAA is not appropriate for exclusion based on intraoperative evaluations
• 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
• Pregnancy or desire to get pregnant within 12-months of the study treatment
• Preoperative need for an intra-aortic balloon pump or intravenous inotropes
• Patients who have been treated with thoracic radiation
• Patients in current chemotherapy
• Patients on long term treatment with steroids not including intermittent use of inhaled steroids for respiratory diseases.
• Patients with known connective tissue disorders