Systolic Heart Failure Clinical Trial
Official title:
Spinal Cord Stimulation For Heart Failure As A Restorative Treatment
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
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).
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