MASA Valve Early Feasibility Study

Exclusion Criteria

• •1. Patient is in need of or has presence of a prosthetic heart valve at any other position
• •2. Patient has a need for concomitant surgical procedures (non-cardiac)
• •3. Patients with previously implanted pacemaker (including defibrillators) or mechanical valves
• •4. Patient has an active bacterial or viral infection or requiring current antibiotic therapy (if temporary illness, patient may be a candidate 4 weeks after discontinuation of antibiotics)
• •5. Patient has an active endocarditis
• •6. Leukopenia, according to local laboratory evaluation of white blood cell count
• •7. Acute or chronic anemia, according to local laboratory evaluation of hemoglobin Patients can be transfused to meet eligibility criteria
• •8. Thrombocytopenia, defined as Platelet count \< 150,000/mm3 Patients can be transfused to meet eligibility criteria
• •9. Severe chest wall deformity, which would preclude placement of the PV conduit
• •10. Known hypersensitivity to anticoagulants and antiplatelet drugs and to the device materials
• •11. Immunocompromised patient defined as: autoimmune disease, patients receiving immunosuppressant drugs or immune stimulant drugs
• •12. Patient has chronic inflammatory / autoimmune disease
• •13. Need for emergency cardiac or vascular surgery or intervention
• •14. Major or progressive non-cardiac disease (liver failure, renal failure, cancer) that has a life expectancy of less than one year
• •15. Currently participating, or participated within the last 30 days, in an investigational drug or device study
• •16. Alcohol or drug abuse as defined by DSM IV-TR criteria for substance abuse - this includes the illicit use of cannabis within the last 12 months
• •17. Patient has medical, social or psychosocial factors that, in the opinion of the Investigator, could have impact on safety or compliance