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

Prior treatment

• IV inotropes, hemofiltration, or any form of positive inotropic support within 30 days prior to implant
• Myocardial infarction within 90 days prior to implant
• Undergone a CABG procedure within 90 days or a PTCA procedure within 30 days of implant
• Prior heart transplant or ventricular assist device
• 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

Other illness

• Primary heart failure due to uncorrected mitral valve disease, or mitral valve repair or clip within 90 days of implant
• Participating in a cardiac investigational study at the same time

Other

• Mechanical tricuspid valve
• 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.

• Patient provides written authorization and/or consent per institution and geographical requirements
• Male or non-pregnant female, aged 18 or older
• Left ventricular ejection fraction of 25-45% (inclusive, per site assessment)
• NYHA Class III heart failure symptoms
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Patient has been treated with guideline-directed medical therapy