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

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

The purpose of this study is to determine the feasibility of spinal cord stimulation (SCS) as a chronic therapy for systolic 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