Determining the Feasibility of Spinal Cord Neuromodulation for the Treatment of Chronic Heart Failure

Inclusion criteria

• Left Ventricular Ejection Fraction (LVEF) of 35 percent or less
• New York Heart Association (NYHA) functional Class III at time of screening
• QRS duration less than 120 milliseconds (ms)
• Left Ventricular End Diastolic Diameter (LVEDD) of 55 millimeters (mm) to 80 mm as determined by echocardiography within the past 6 months
• Receiving stable optimal medical therapy for heart failure prior to enrollment
• Serum creatinine less than or equal to 3.0 milligrams per deciliter (mg/dL)
• 18 years of age or older
• Willing and able to comply with study procedures
• Expected lifespan greater than 12 months beyond study enrollment as assessed by physician

Exclusion criteria

• Interruption of thromboprophylaxis (e.g., heparin, LMWH, warfarin, aspirin, dabigatran, clopidogrel) would pose an unacceptable health risk (e.g., patient with an abnormal bleeding time), as determined by physician
• Polyneuropathy
• Requires diathermy including shortwave diathermy, microwave diathermy, or therapeutic ultrasound diathermy
• Unable to perform an exercise capacity test
• Pregnant or planning to become pregnant during this study
• Currently enrolled or plans to enroll in another investigational device or drug study that may confound the results of this study
• Had Coronary Artery Bypass Graft/Percutaneous Coronary Intervention/Bare Metal Stent (CABG/PCI/BMS) procedures within the past 90 days
• Had a heart transplant
• Has complete heart block
• Had Acute Coronary Syndrome within the past 90 days
• Has congenital heart disease with significant hemodynamic shunting
• Has chemotherapy-induced heart failure
• Has reversible cardiomyopathy
• Has severe mitral regurgitation (greater than 60 percent regurgitant fraction or greater than 0.3 centimeters squared (cm2) regurgitant orifice area)
• Has diagnosed unstable angina pectoris
• Has unstable coronary artery disease
• Has a Cardiac Resynchronization Therapy (CRT) device implanted and is receiving CRT therapy
• Has a non-Medtronic Implantable Cardioverter Defibrillator (ICD), pacemaker, or any non-transvenous defibrillation lead
• Has a Medtronic ICD whose sensing threshold cannot be programmed to 0.3mV or greater
• Has an existing neurostimulator