Carmat TAH Early Feasibility Study

Exclusion Criteria

• •1. Known intolerance to anticoagulant or antiplatelet therapies or known Heparin Induced Thrombocytopenia.
• •2. Presence of any non-temporary mechanical circulatory support
• •3. Presence of temporary mechanical circulatory support such as Impella (all types) or IABP with a duration greater than 21 days
• •4. Presence of ECMO with a duration greater than 7 days
• •5. Patient is intubated and unconscious, or intubated and not awake
• •6. Coagulopathy defined by platelets \< 100k/µl or INR ≥ 1.5 not due to anticoagulant therapy.
• •7. Cerebrovascular accident \< 3 months or symptomatic or a known \> 80% carotid stenosis.
• •8. Known abdominal or thoracic aortic aneurysm \> 5 cm that has not been treated.
• •9. Severe end-organ dysfunction as per any of the following criteria:
• •1. Total bilirubin \> 2.5 mg/dl or cirrhosis evidenced by ultrasound, CT-scan and positive biopsy
• •2. eGFR \< 30ml/min/1.73m2 or the need for chronic renal replacement therapy
• •10. History of severe Chronic Obstructive Pulmonary Disease with FEV1/FVC \<0.7, or FEV1\<50% predicted or severe restrictive lung disease.
• •11. Recent blood stream infection (\<7 days).
• •12. Documented amyloid light-chain (AL amyloidosis).
• •13. Hemodynamically significant peripheral vascular disease with documented ankle- brachial pressure index (ABPI) \<0.3.
• •14. Illness, other than heart disease, that would limit survival to less than 2 years.
• •15. Irreversible cognitive dysfunction, psychosocial issues or psychiatric disease, likely to impair compliance with the study protocol and TAH management that in the opinion of the investigator could interfere with the ability to manage the therapy (i.e. non-compliance to heart failure therapy, uncontrolled diabetes, mental health issue, etc.).
• •16. Current or planned pregnancy or breast feeding (woman of childbearing age will have to show negative pregnancy test).
• •17. Patient is currently enrolled or has participated in the last 30 days in another therapeutic or interventional clinical study that is likely to confound the study results or affect the study.