AtriCure Exclusion of the LAA in Patients Undergoing Concomitant Cardiac Surgery
Condition: Left Atrial Appendage Exclusion
Intervention: AtriCure LAA Exclusion System
Intervention description: Exclusion of the left atrial appendage using the AtriCure LAA Exclusion System
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 70.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: left atrial appendage; laa; atrial fibrillation; afib; af; stroke; tia

Summary:

      Prospective, non-randomized trial to evaluate the safety and efficacy of the LAA Exclusion
      Device (Clip) for the exclusion of the LAA via epicardial tissue approximation.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subject is greater than or equal to 18 years of age.

          2. 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)

          3. 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.

          4. Subject is willing and able to provide written informed consent.

          5. Subject has a life expectancy of at least 1 year.

          6. Subject is willing and able to return for scheduled follow-up visits.

        Exclusion Criteria:

          1. Previous cardiac surgery

          2. Thrombus in the LAA/LA which cannot be evacuated prior to placement of the Clip.

          3. Patients requiring surgery other than CABG and/or cardiac valve and/or surgical maze
             procedure and/or PFO closure and/or ASD repair.

          4. NYHA Class IV heart failure symptoms

          5. Need for emergent cardiac surgery (i.e. cardiogenic shock)

          6. Creatinine >200 µmol/L

          7. LAA is not appropriate for exclusion based on intraoperative evaluations

          8. Current diagnosis of active systemic infection

          9. Renal failure requiring dialysis or hepatic failure

         10. A known drug and/or alcohol addiction

         11. Mental impairment or other conditions which may not allow the subject to understand
             the nature, significance and scope of the study

         12. Pregnancy or desire to get pregnant within 12-months of the study treatment

         13. Preoperative need for an intra-aortic balloon pump or intravenous inotropes

         14. Patients who have been treated with thoracic radiation

         15. Patients in current chemotherapy

         16. Patients on long term treatment with steroids not including intermittent use of
             inhaled steroids for respiratory diseases.

         17. Patients with known connective tissue disorders