Phase 2
N=66
Determining the Feasibility of Spinal Cord Neuromodulation for the Treatment of Chronic Heart Failure
Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT01112579 ↗Enrolled (actual)
66
Serious AEs
69.7%
Results posted
Oct 2015
Primary outcome: 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. — 2.8; -3.6 mL/m2 — p=0.3
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Medtronic PrimeADVANCED Neurostimulator (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Primary completion
- Jan 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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. |
2.8; -3.6 | 0.3 |
| SECONDARY Characterize the Change in proBNP Between the Treatment Arm and Control Arm Through 6 Months |
-32.4; 73.8 | 0.79 |
| SECONDARY Characterize the Change in Peak Oxygen Uptake Between the Treatment Arm and Control Arm Through 6 Months |
0.6; -0.2 | 0.93 |
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
Data sourced from ClinicalTrials.gov (NCT01112579). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.