Spinal Cord Stimulation For Heart Failure (SCS HEART)

This is an interventional treatment trial for Systolic Heart Failure focused on measuring spinal cord stimulation, systolic heart failure Read More

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 SJM CRT-D device implanted >90 days and is receiving stable medical therapy for HF (>90 days) 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 in this 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 an implanted spinal cord stimulator which is now explanted
• Patient has polyneuropathy
• Patient requires short-wave diathermy, microwave diathermy or therapeutic ultrasound diathermy
• 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 revascularization procedure(percutaneous coronary intervention or coronary artery bypass graft) <90 days at 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: systemic corticosteroids, 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 adequate contraceptive methods, or nursing
• Patient with a bleeding tendency (International Normalized Ratio, INR >1.2 and platelet 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