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

Completed · Phase 2

Conditions studied: Heart Failure

In brief

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

Key facts

Study ID

NCT01112579

Run by

Medtronic Cardiac Rhythm and Heart Failure

People needed

81

Starts

2010-04-01

Expected to finish

2015-04-01

Last updated by the study team

2015-10-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Miami, Florida, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Allentown, Pennsylvania, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Burlington, Vermont, United States
• Study site — Spokane, Washington, United States
• Study site — Vancouver, British Columbia, Canada
• Study site — Victoria, British Columbia, Canada
• Study site — Prague, Czechia
• Study site — Berlin, Germany
• Study site — Herne, Germany
• Study site — Rome, Italy
• Study site — Groningen, Netherlands
• Study site — Maastricht, Netherlands
• Study site — Zwolle, Netherlands
• Study site — Cape Town, South Africa
• Study site — Johannesburg, South Africa
• Study site — Gothenburg, Sweden
• Study site — Stockholm, Sweden

Full record on ClinicalTrials.gov

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