Determining the Feasibility of Spinal Cord Neuromodulation for the Treatment of Chronic Heart Failure (DEFEAT-HF)

Medtronic

Status and phase

Completed

Phase 2

Conditions

Heart Failure

Treatments

Device: Medtronic PrimeADVANCED Neurostimulator

Study type

Interventional

Funder types

Industry

Identifiers

DEFEAT-HF

Details and patient eligibility

About

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

Enrollment

81 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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