Thoratec HeartMate II Left Ventricular Assist System (LVAS) for Destination Therapy

Inclusion Criteria: The following are general criteria; more specific conditions are included in the studyprotocol:

• Subjects with advanced heart failure symptoms (NYHA Class IIIB or IV) who are:
• On optimal medical management and are failing to respond; or
• In Class III or Class IV heart failure and dependent on IABP and/or inotropes; or
• Treated with ACE inhibitors or beta-blockers and found to be intolerant.
• Ineligible for cardiac transplant
• VO2max <=14 ml/kg/min
• LVEF <=25%

Exclusion Criteria: The following are general criteria; more specific conditions are included in the studyprotocol:

• Evidence of, or risk factors for end-organ dysfunction that would make LVASimplantation futile
• Existence of factors that would adversely affect patient survival or function of theLVAS
• Intolerance to anticoagulant or antiplatelet therapies.
• Existence of any ongoing mechanical circulatory support other than intra-aorticballoon counterpulsation.
• Participation in any other clinical investigation that is likely to confound studyresults or affect study outcome