This trial is active, not recruiting.

Condition heart failure
Treatments medtronic primeadvanced neurostimulator
Phase phase 2
Sponsor Medtronic Cardiac Rhythm Disease Management
Start date April 2010
End date September 2014
Trial size 250 participants
Trial identifier NCT01112579, Defeat-HF


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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
medtronic primeadvanced neurostimulator Medtronic PrimeADVANCED Neurostimulator
Heart failure therapy
medtronic primeadvanced neurostimulator Medical management
Medical management

Primary Outcomes

Change in left ventricular volumes as measured by cardiac echo
time frame: Baseline and 6 months

Secondary Outcomes

Blood chemistry change as measured by proBNP
time frame: Baseline and 6 Months
Exercise capacity change as measured by peak oxygen uptake
time frame: Baseline and 6 Months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Determining the Feasibility of Spinal Cord Neuromodulation for the Treatment of Chronic Heart Failure
Principal investigator Douglas P Zipes, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in March 2014.
Information provided to ClinicalTrials.gov by Medtronic Cardiac Rhythm Disease Management.