Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    "SCS HEART"
Previous Study | Return to List | Next Study

Spinal Cord Stimulation For Heart Failure (SCS HEART)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01362725
Recruitment Status : Completed
First Posted : May 30, 2011
Last Update Posted : February 4, 2019
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

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

Condition or disease Intervention/treatment Phase
Systolic Heart Failure Device: Spinal cord stimulation system Phase 2 Phase 3

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).


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
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.
Other Names:
  • Eon Mini Neurostimulation System,
  • Octrode® percutaneous lead (Model 3186),
  • Eon Mini IPG (Model 3788),
  • Eon Patient ProgrammerTM (Model 3851),
  • Multi-program trial stimulator (Model 3510),
  • Rapid programmer (Model 3832),
  • Eon Mini Charging System (Model 3721).
  • Similar St. Jude Medical commercially available neurostimulation system with the same capabilities may also be used.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. long-term safety [ Time Frame: 24 months ]
    post procedural adverse events



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
Layout table for location information
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
Hong Kong
Queen Mary Hospital
Hong Kong, Hong Kong
Japan
Osaka University Hospital
Osaka, Japan
University of Tokyo Hospital
Tokyo, Japan
Sponsors and Collaborators
Abbott Medical Devices
Investigators
Layout table for investigator information
Principal Investigator: Hung-Fat Tse, MD The University of Hong Kong, Queen Mary Hospital

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT01362725     History of Changes
Other Study ID Numbers: CI-10-029-ID-SC
First Posted: May 30, 2011    Key Record Dates
Last Update Posted: February 4, 2019
Last Verified: January 2019
Keywords provided by Abbott Medical Devices:
spinal cord stimulation
systolic heart failure
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Failure
Heart Failure, Systolic
Heart Diseases
Cardiovascular Diseases