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