Spinal Cord Stimulation For Heart Failure (SCS HEART)
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|ClinicalTrials.gov Identifier: NCT01362725|
Recruitment Status : Completed
First Posted : May 30, 2011
Last Update Posted : February 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|Systolic Heart Failure||Device: Spinal cord stimulation system||Phase 2 Phase 3|
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Spinal Cord Stimulation For Heart Failure As A Restorative Treatment|
|Study Start Date :||April 2011|
|Actual Primary Completion Date :||August 2014|
|Actual Study Completion Date :||January 2016|
|Experimental: Spinal cord stimulation||
Device: Spinal cord stimulation system
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.
- Safety and efficacy markers [ Time Frame: 6 months ]Intra and post procedure adverse events, exercise and functional capacity, left ventricular structure and function, inflammatory condition, and quality of life.
- long-term safety [ Time Frame: 24 months ]post procedural adverse events
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01362725
|Australia, New South Wales|
|John Hunter Hospital|
|New Lambton Heights, New South Wales, Australia, 2305|
|Australia, South Australia|
|Royal Adelaide Hospital|
|Adelaide, South Australia, Australia, 5000|
|Queen Mary Hospital|
|Hong Kong, Hong Kong|
|Osaka University Hospital|
|University of Tokyo Hospital|
|Principal Investigator:||Hung-Fat Tse, MD||The University of Hong Kong, Queen Mary Hospital|