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

Study Overview
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Brief Summary
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The purpose of this study is to determine the feasibility of spinal cord stimulation (SCS) as a chronic therapy for systolic heart failure.

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

Conditions
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Heart Failure

Intervention / Treatment
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* Device: Medtronic PrimeADVANCED Neurostimulator
* Device: Medtronic PrimeADVANCED Neurostimulator


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br> | Device: Medtronic PrimeADVANCED Neurostimulator<br>* Heart failure therapy<br>|
| Other: Control<br> | Device: Medtronic PrimeADVANCED Neurostimulator<br>* Medical management<br>* Other names: Medical management;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the Reduction in Left-ventricular End Systolic Volume Index (LVESVi) After 6 Months of Spinal Cord Stimulation (SCS) Therapy in the Treatment Arm Compared to the Control Arm. |  | Baseline and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterize the Change in proBNP Between the Treatment Arm and Control Arm Through 6 Months |  | Baseline and 6 Months | 
| Characterize the Change in Peak Oxygen Uptake Between the Treatment Arm and Control Arm Through 6 Months |  | Baseline and 6 Months |