Heart Failure Clinical Trial
Official title:
The Treatment of Spinal Cord Stimulation in Severe Heart Failure
Previous studies have shown that spinal cord stimulation (SCS) may improve cardiac output and decrease the risk of ischemic ventricular arrhythmia in animal model and its safety profile in human trial. The purposes of this study are to evaluate the feasibility, treatment efficacy and safety of SCS in patients with severe symptomatic heart failure (HF).
Morbidity and mortality in heart failure (HF) patients remain high, even with recent
advances in therapies. Previous studies have shown that the autonomic nervous system plays
an important role in the pathophysiology of HF and sudden cardiac death.
Spinal cord stimulation (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. The SCS system
consists of an implantable pulse generator (IPG) and dual leads. 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 benefit HF patients.
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