Performance of the CARDIOGARD Cannula
Performance of the CARDIOGARD Cannula
This is a single center, prospective study:

 The 'CardioGard Cannula' Gaseous emboli capture results - shows an improvement from the
 control group.
Patients referred for CPB procedure will be offered to participate in the study. Patients
 will be asked to sign an informed consent form (ICF), prior to performing any study related
 procedures.

 The point of enrollment is the time at which a patient signs and dates the ICF. Following
 enrollment, the patient will undergo screening evaluation (including Neurological assessment)
 to determine eligibility. Screening failures will be identified on a screening log. Patients
 who are found to meet all inclusion criteria and none of the exclusion criteria will compose
 the evaluable cohort of the study. Screening failure subjects will not be counted as part of
 the target patient sample size nor will they be included in the analysis.

 Patients in the randomized phase will have surgery with the CardioGard Cannula or comparator
 cannulae and will remain blinded to their group assignment through the 30 days follow-up
 evaluation.
Inclusion Criteria:

 1. Patient indicated for first-time non-emergent procedure under cardiopulmonary bypass
 which is expected to last up to 6 hours.

 2. Patient undergoing an elective isolated coronary artery bypass surgery (CABG), or an
 elective isolated aortic/mitral valve replacement (AVR/MVR) or an elective combined
 aortic/mitral valve replacement (AVR/MVR) with coronary artery bypass surgery (CABG).

 3. The patient is >50 and <85 years of age.

 4. The patient's body weight is compatible with blood net flow of 4 - 5 [l/min].

 5. Patient with left ventricular ejection fraction >30% as assessed by either
 echocardiography, angiography or by radio nuclear assessment (MUGA)

 6. The patient is willing to participate as evidenced by signing the written informed
 consent.

 7. Male or non-pregnant female patient (Note: Females of child bearing potential must
 have a negative pregnancy test)

 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.