Systolic Heart Failure
Conditions
Keywords
spinal cord stimulation, systolic heart failure
Brief summary
The primary objectives of this feasibility study are to determine the safety of spinal cord stimulation (SCS) as a therapy in patients with systolic heart failure and to gather observational information for potential efficacy markers
Detailed description
Morbidity and mortality in heart failure patients remain relatively high, even with recent advances in therapies. Previous studies show that the autonomic nervous system plays an important role in the pathophysiology of heart failure (HF)and sudden cardiac death. SCS is a neurostimulation therapy, which involves the stimulation of selected nerve fibers and intends to create end-organ responses characterized by changes in blood flow, decrease of catecholamines and reduction in inflammation. These changes that occur due to SCS are shown to be effective in reducing the symptoms of chronic angina and pain secondary to peripheral vascular disease where both situations are characterized by decreased blood flow and inflammation. The SCS system consists of an implantable pulse generator(IPG) and lead(s). Each lead has electrodes on the distal end. Electrical impulses travel from the IPG through the leads to the electrodes positioned at the selected nerve fibers to provide the therapeutic stimulation. By virtue of its potential in augmenting blood flow, decreasing catecholamines and reducing inflammation, SCS may further benefit patients with heart failure (HF).
Interventions
An implantable pulse generator (IPG) will deliver low-intensity electrical pulses which travel from the IPG through the leads to the electrodes positioned at the selected nerve fibers to provide the therapeutic stimulation.
Sponsors
Abbott Medical Devices
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
No
Inclusion criteria
* Patients has a LVEF between 20% and 35% * Patient is in NYHA Class III or in Ambulatory Class IV * Patient has had a SJM implantable cardioverter defibrillator (ICD) device or a SJM CRT-D device implanted \>90 days and is receiving stable medical therapy for HF (\>90 days) at Baseline * Patient has a LV end diastolic diameter between 55mm and 80mm * Patient must be able and willing to provide written informed consent to participate in this study * Patient must be able and willing to comply with the required follow-up schedule
Exclusion criteria
* Patient currently has an implanted spinal cord stimulator or previously had an implanted spinal cord stimulator which is now explanted * Patient has polyneuropathy * Patient requires short-wave diathermy, microwave diathermy or therapeutic ultrasound diathermy * Patient has received a tissue / organ transplant (or is expected to have a tissue / organ transplant within the next 180 days) * Patient has persistent or permanent Atrial Fibrillation (AF) * Patient has chronic refractory angina or peripheral vascular pain * Patient has critical valvular heart disease that requires valve repair or replacement * Patient has had a myocardial infarction (MI) or cardiac revascularization procedure(percutaneous coronary intervention or coronary artery bypass graft) \<90 days at Baseline or is expected to have this in the next 180 days * Patient is on IV inotropic therapy * Patient has active myocarditis or early postpartum cardiomyopathy * Patient has taken any of the following drugs within 30 days of enrollment: systemic corticosteroids, cytostatic and immunosuppressive drug therapy (cyclophosphamide, methotrexate, cyclosporine, azathioprine, etc.), DNA depleting or cytotoxic drugs * Patient is pregnant, or of childbearing potential and is not using adequate contraceptive methods, or nursing * Patient with a bleeding tendency (International Normalized Ratio, INR \>1.2 and platelet count \<100 x109 per liter) * Patient has a local infection at the ICD implant location or systemic infection * Patient has renal insufficiency (creatinine \>3.0 mg/dl) * Patient is participating in another clinical study * Patient is less than 18 years old * Patient's life's expectancy is less than 1 year as assessed by investigators
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and efficacy markers | 6 months | Intra and post procedure adverse events, exercise and functional capacity, left ventricular structure and function, inflammatory condition, and quality of life. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| long-term safety | 24 months | post procedural adverse events |
Countries
Australia, Hong Kong, Japan
Outcome results
None listed