Corheart 6 LVAS Study

Exclusion Criteria32

• \. Heart failure who can be treated with other therapy options (e.g. CRT, CRT-D, etc.)
• \. Intolerance to anticoagulant or antiplatelet therapies or any other peri/post-operative therapy the investigator will require based upon the patients' health status.
• \. Patient has known hypo or hyper coagulable states such as disseminated intravascular coagulation and heparin induced thrombocytopenia type II.
• \. Platelet count \< 100,000 x 10\^3/L (\< 100,000/ml).
• \. Psychiatric disease/ disorder, irreversible cognitive dysfunction or psychosocial issues that are likely to impair compliance with the study protocol and ventricular assist system management.
• \. Technical obstacles which pose an inordinately high surgical risk, in the judgment of the investigator.
• \. Presence of an active, uncontrolled infection.
• \. Presence of any one of the following risk factors for indications of severe end organ dysfunction or failure:
• a. Total bilirubin \> 51.3 μmol/L (3.0 mg/dl), ischemic hepatitis, or biopsy proven liver cirrhosis, or clinically Child-Pugh B and C score.
• b. History of severe chronic obstructive pulmonary disease (COPD) defined by FEV1/FVC \< 0.7, or FEV1 \< 50% predicted.
• c. Fixed pulmonary hypertension with a most recent PVR ≥ 8 Wood units that is unresponsive to pharmacologic intervention.
• d. History of stroke within 180 days prior to enrollment, or a history of cerebrovascular disease with symptomatic (\> 70%) carotid artery stenosis
• e. Serum creatinine ≥ 265 μmol/L (3.0mg/dl) or requiring dialysis.
• f. Significant peripheral vascular disease (PVD) accompanied by rest pain or extremity ulceration.
• \. Etiology of heart failure (HF) due to or associated with uncorrected thyroid disease, obstructive/ restrictive cardiomyopathy, pericardial disease, amyloidosis or giant cell myocarditis.
• \. Uncorrected moderate to severe aortic insufficiency without plans for correction during pump implant.
• \. History of confirmed, untreated abdominal aortic aneurysm (AAA) or thoracic aortic aneurysm (TAA) \> 5 cm in diameter.
• \. Uncontrollable ventricular tachyarrythmias/ ventricular fibrillation (VF).
• \. STEMI \<2 weeks before planned implantation.
• \. Right ventricular failure as defined by one or more of the following:
• a. severe depressed RV function in echocardiography
• b. TAPSE \< 1.0 cm
• c. CVP/PCWP ratio \> 0.63
• \. Planned Bi-VAD support prior to enrollment.
• \. Cardiac arrest with a history of resuscitation 1-month before inclusion, without full restoration of cognitive function.
• \. History of any organ transplant.
• \. Pre albumin \< 150 mg/L, or Albumin \< 30g/L (3 g/dL).
• \. Any condition other than HF that could limit survival to less than 24 months.
• \. Positive pregnancy test if of childbearing potential.
• \. Lactating mothers.
• \. Participation in any other clinical investigation that is likely to confound study results or affect the study.
• \. Patients who have been placed in an institution by court order or by order of the authorities.