Performance of the CARDIOGARD Cannula

Exclusion Criteria

• •1. Patient with abnormal clotting mechanism: PT 60%, PTT\>2 the normal.
• •2. Patient with an aortic trauma.
• •3. Patient contraindicated for open heart surgery under bypass machine.
• •4. Patient undergoing a re-do procedure.
• •5. Patient intended for an operation performed using minimally invasive surgical techniques (e.g., mini-sternotomy)
• •6. Patient with pathologies which affect his/her neurological condition.
• •7. Patient in whom emergency operation is required.
• •8. Patient with a known allergy to Heparin
• •9. Patient with major co-morbid condition(s) that could limit the patient's ability to participate in the study, or impact the scientific integrity of the study, including but not limited to:
• •* previous stroke
• •* critical preoperative state
• •* poor ventricular function
• •* severe pulmonary hypertension \[19\]
• •* Atheroembolism
• •* history of cardiac failure \[20\]
• •10. Current use of drugs that might result in high surgical risk or significant postoperative complication.
• •11. Psychological instability, inappropriate attitude or motivation.
• •12. Patients with life threatening debilitating disease other than cardiac.
• •13. Subjects currently enrolled in another investigational device or drug trial that has not completed the primary end point or that clinically interferes with the current study endpoints.