Post Approval Study (PAS) of the OPTIMIZER Smart and CCM Therapy

Exclusion Criteria

• •1. Primary heart failure due to uncorrected mitral valve disease, or mitral valve repair or clip within 90 days of implant
• •2. IV inotropes, hemofiltration, or any form of positive inotropic support within 30 days prior to implant
• •3. Myocardial infarction within 90 days prior to implant
• •4. Undergone a CABG procedure within 90 days or a PTCA procedure within 30 days of implant
• •5. Prior heart transplant or ventricular assist device
• •6. Mechanical tricuspid valve
• •7. Receiving cardiac resynchronization therapy (CRT) or has a Class I indication for CRT implantation according to the ACCF/AHA/HRS guidelines for device-based therapy
• •8. Participating in a cardiac investigational study at the same time
• •9. Patient is in a vulnerable population (such as significant mental disability, prisoner) that in the judgement of the PI impedes ability to provide informed consent.