Spinal Cord Stimulation For Heart Failure

Inclusion Criteria:

• Patients has a LVEF between 20% and 35%

• Patient is in NYHA Class III or in Ambulatory Class IV

• Patient has had a SJM implantable cardioverter defibrillator (ICD) device or a SJMCRT-D device implanted >90 days and is receiving stable medical therapy for HF (>90days) at Baseline

• Patient has a LV end diastolic diameter between 55mm and 80mm

• Patient must be able and willing to provide written informed consent to participate inthis study

• Patient must be able and willing to comply with the required follow-up schedule

Exclusion Criteria:

• Patient currently has an implanted spinal cord stimulator or previously had animplanted spinal cord stimulator which is now explanted

• Patient has polyneuropathy

• Patient requires short-wave diathermy, microwave diathermy or therapeutic ultrasounddiathermy

• Patient has received a tissue / organ transplant (or is expected to have a tissue /organ transplant within the next 180 days)

• Patient has persistent or permanent Atrial Fibrillation (AF)

• Patient has chronic refractory angina or peripheral vascular pain

• Patient has critical valvular heart disease that requires valve repair or replacement

• Patient has had a myocardial infarction (MI) or cardiac revascularizationprocedure(percutaneous coronary intervention or coronary artery bypass graft) <90 daysat Baseline or is expected to have this in the next 180 days

• Patient is on IV inotropic therapy

• Patient has active myocarditis or early postpartum cardiomyopathy

• Patient has taken any of the following drugs within 30 days of enrollment: systemiccorticosteroids, cytostatic and immunosuppressive drug therapy (cyclophosphamide,methotrexate, cyclosporine, azathioprine, etc.), DNA depleting or cytotoxic drugs

• Patient is pregnant, or of childbearing potential and is not using adequatecontraceptive methods, or nursing

• Patient with a bleeding tendency (International Normalized Ratio, INR >1.2 andplatelet count <100 x109 per liter)

• Patient has a local infection at the ICD implant location or systemic infection

• Patient has renal insufficiency (creatinine >3.0 mg/dl)

• Patient is participating in another clinical study

• Patient is less than 18 years old

• Patient's life's expectancy is less than 1 year as assessed by investigators