Performance of the CARDIOGARD Cannula (GECG)

This is an interventional prevention trial for Heart Valve Diseases focused on measuring Cardiopulmonary Bypass Read More

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.