European Clinical Evaluation of the Carmat Total Artificial Heart

Exclusion Criteria

• •1. Body Mass Index (BMI) \< 15 or \> 47
• •2. Existence of any ongoing non-temporary mechanical circulatory support
• •3. Existence of any temporary mechanical circulatory support other than IABP and Impella
• •4. History of cardiac or other organ transplant
• •5. Patients who have required cardiopulmonary resuscitation for \> 30 minutes within 14 days prior to implant
• •6. Known intolerance to anticoagulant or antiplatelet therapies
• •7. Coagulopathy defined by platelets \< 100k/μl or INR ≥ 1.5 not due to anticoagulant therapy
• •8. Cerebro-vascular accident \< 3 months or symptomatic or a known \> 80% carotid stenosis
• •9. Known abdominal or thoracic aortic aneurysm \> 5 cm
• •10. End-organ dysfunction as per investigator judgment and following but not limited criteria:
• •1. Total bilirubin \> 100 μmol/L (5,8 mg/dl) or cirrhosis evidenced by ultrasound, CT-scan or positive biopsy
• •2. GFR \< 30ml/min/1.73m2
• •11. History of severe Chronic Obstructive Pulmonary Disease or severe restrictive lung disease
• •12. Recent blood stream infection (\<7 days)
• •13. Documented amyloid light-chain (AL amyloidosis)
• •14. Hemodynamically significant peripheral vascular disease accompanied by rest pain or extremity ulceration
• •15. Illness, other than heart disease, that would limit survival to less than 1 year
• •16. Irreversible cognitive dysfunction, psychosocial issues or psychiatric disease, likely to impair compliance with the study protocol and TAH management
• •17. Participation in any other clinical investigation that is likely to confound study results or affect the study
• •18. Pregnancy or breast feeding (woman in age of childbearing will have to show negative pregnancy test)