Spinal Cord Stimulation in Heart Failure

This is an interventional treatment trial for Heart Failure focused on measuring Heart failure, Spinal cord stimulation Read More

Inclusion Criteria:

• Patients has a left ventricular ejection fraction between 20% and 35%
• Patient is in New York Heart Association Class III or in Ambulatory Class IV
• Patient is receiving stable medical therapy for HF (>90 days) at baseline
• Patient has a left ventricular end diastolic diameter between 55 mm and 80 mm
• 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 upper thoracic 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
• 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 >1.2 and platelet count <100 x10^9 per liter)
• Patient has a local infection at the implantable cardioverter-defibrillator (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 20 years old
• Patient's life's expectancy is less than 1 years as assessed by investigator