Determining the Feasibility of Spinal Cord Neuromodulation for the Treatment of Chronic Heart Failure
Condition: Heart Failure
MeSH terms: Heart Failure
Intervention: Medtronic PrimeADVANCED Neurostimulator; Medtronic PrimeADVANCED Neurostimulator
Intervention description: Heart failure therapy; Medical management
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 81.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

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

Eligibility criteria:

        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