Heart Failure
Conditions
Brief summary
The purpose of this study is to determine the feasibility of spinal cord stimulation (SCS) as a chronic therapy for systolic heart failure.
Interventions
DEVICEMedtronic PrimeADVANCED Neurostimulator
Heart failure therapy
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
Canada, Czechia, Germany, Italy, Netherlands, South Africa, Sweden, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment Medtronic PrimeADVANCED Neurostimulator: Heart failure therapy | 42 |
| Control Medtronic PrimeADVANCED Neurostimulator: Medical management | 24 |
| Total | 66 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 0 | 2 |
| Overall Study | Missed Visit | 1 | 1 |
Baseline characteristics
| Characteristic | Treatment | Control | Total |
|---|---|---|---|
| Age, Continuous | 58 years STANDARD_DEVIATION 11 | 66 years STANDARD_DEVIATION 11 | 61 years STANDARD_DEVIATION 12 |
| Region of Enrollment Canada | 3 Randomized participants | 0 Randomized participants | 3 Randomized participants |
| Region of Enrollment Czech Republic | 12 Randomized participants | 10 Randomized participants | 22 Randomized participants |
| Region of Enrollment Germany | 1 Randomized participants | 0 Randomized participants | 1 Randomized participants |
| Region of Enrollment Italy | 3 Randomized participants | 0 Randomized participants | 3 Randomized participants |
| Region of Enrollment Netherlands | 9 Randomized participants | 5 Randomized participants | 14 Randomized participants |
| Region of Enrollment South Africa | 1 Randomized participants | 1 Randomized participants | 2 Randomized participants |
| Region of Enrollment Sweden | 4 Randomized participants | 5 Randomized participants | 9 Randomized participants |
| Region of Enrollment United States | 9 Randomized participants | 3 Randomized participants | 12 Randomized participants |
| Sex: Female, Male Female | 10 Participants | 4 Participants | 14 Participants |
| Sex: Female, Male Male | 32 Participants | 20 Participants | 52 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 19 / 42 | 12 / 24 |
| serious Total, serious adverse events | 30 / 42 | 16 / 24 |
Outcome results
Primary
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.
Time frame: Baseline and 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | 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. | 2.8 mL/m2 | Standard Deviation 16 |
| Control | 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. | -3.6 mL/m2 | Standard Deviation 14.9 |
p-value: 0.395% CI: [-2, 14.9]ANCOVA
Secondary
Characterize the Change in Peak Oxygen Uptake Between the Treatment Arm and Control Arm Through 6 Months
Time frame: Baseline and 6 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Characterize the Change in Peak Oxygen Uptake Between the Treatment Arm and Control Arm Through 6 Months | 0.6 mL/kg/min | Standard Deviation 4.1 |
| Control | Characterize the Change in Peak Oxygen Uptake Between the Treatment Arm and Control Arm Through 6 Months | -0.2 mL/kg/min | Standard Deviation 3.3 |
p-value: 0.9395% CI: [-1.6, 3.2]ANCOVA
Secondary
Characterize the Change in proBNP Between the Treatment Arm and Control Arm Through 6 Months
Time frame: Baseline and 6 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Characterize the Change in proBNP Between the Treatment Arm and Control Arm Through 6 Months | -32.4 pg/mL | Standard Deviation 994 |
| Control | Characterize the Change in proBNP Between the Treatment Arm and Control Arm Through 6 Months | 73.8 pg/mL | Standard Deviation 1468 |
p-value: 0.7995% CI: [-845.8, 633.6]ANCOVA