Spinal Cord Stimulation For Heart Failure (SCS HEART)
Primary Purpose
Systolic Heart Failure
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Spinal cord stimulation system
Sponsored by
About this trial
This is an interventional treatment trial for Systolic Heart Failure focused on measuring spinal cord stimulation, systolic heart failure
Eligibility 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
Sites / Locations
- John Hunter Hospital
- Royal Adelaide Hospital
- Queen Mary Hospital
- Osaka University Hospital
- University of Tokyo Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Spinal cord stimulation
Arm Description
Outcomes
Primary Outcome Measures
Safety and efficacy markers
Intra and post procedure adverse events, exercise and functional capacity, left ventricular structure and function, inflammatory condition, and quality of life.
Secondary Outcome Measures
long-term safety
post procedural adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01362725
Brief Title
Spinal Cord Stimulation For Heart Failure
Acronym
SCS HEART
Official Title
Spinal Cord Stimulation For Heart Failure As A Restorative Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
January 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systolic Heart Failure
Keywords
spinal cord stimulation, systolic heart failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Spinal cord stimulation
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Spinal cord stimulation system
Other Intervention Name(s)
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.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Safety and efficacy markers
Description
Intra and post procedure adverse events, exercise and functional capacity, left ventricular structure and function, inflammatory condition, and quality of life.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
long-term safety
Description
post procedural adverse events
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hung-Fat Tse, MD
Organizational Affiliation
The University of Hong Kong, Queen Mary Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
John Hunter Hospital
City
New Lambton Heights
State/Province
New South Wales
ZIP/Postal Code
2305
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Queen Mary Hospital
City
Hong Kong
Country
Hong Kong
Facility Name
Osaka University Hospital
City
Osaka
Country
Japan
Facility Name
University of Tokyo Hospital
City
Tokyo
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
19597055
Citation
Lopshire JC, Zhou X, Dusa C, Ueyama T, Rosenberger J, Courtney N, Ujhelyi M, Mullen T, Das M, Zipes DP. Spinal cord stimulation improves ventricular function and reduces ventricular arrhythmias in a canine postinfarction heart failure model. Circulation. 2009 Jul 28;120(4):286-94. doi: 10.1161/CIRCULATIONAHA.108.812412. Epub 2009 Jul 13.
Results Reference
background
PubMed Identifier
10946073
Citation
Foreman RD, Linderoth B, Ardell JL, Barron KW, Chandler MJ, Hull SS Jr, TerHorst GJ, DeJongste MJ, Armour JA. Modulation of intrinsic cardiac neurons by spinal cord stimulation: implications for its therapeutic use in angina pectoris. Cardiovasc Res. 2000 Aug;47(2):367-75. doi: 10.1016/s0008-6363(00)00095-x.
Results Reference
background
PubMed Identifier
11873770
Citation
Armour JA, Linderoth B, Arora RC, DeJongste MJ, Ardell JL, Kingma JG Jr, Hill M, Foreman RD. Long-term modulation of the intrinsic cardiac nervous system by spinal cord neurons in normal and ischaemic hearts. Auton Neurosci. 2002 Jan 10;95(1-2):71-9. doi: 10.1016/s1566-0702(01)00377-0.
Results Reference
background
PubMed Identifier
17066119
Citation
Deer TR, Raso LJ. Spinal cord stimulation for refractory angina pectoris and peripheral vascular disease. Pain Physician. 2006 Oct;9(4):347-52.
Results Reference
background
PubMed Identifier
3871177
Citation
Mannheimer C, Carlsson CA, Emanuelsson H, Vedin A, Waagstein F, Wilhelmsson C. The effects of transcutaneous electrical nerve stimulation in patients with severe angina pectoris. Circulation. 1985 Feb;71(2):308-16. doi: 10.1161/01.cir.71.2.308.
Results Reference
background
PubMed Identifier
25500165
Citation
Tse HF, Turner S, Sanders P, Okuyama Y, Fujiu K, Cheung CW, Russo M, Green MDS, Yiu KH, Chen P, Shuto C, Lau EOY, Siu CW. Thoracic Spinal Cord Stimulation for Heart Failure as a Restorative Treatment (SCS HEART study): first-in-man experience. Heart Rhythm. 2015 Mar;12(3):588-595. doi: 10.1016/j.hrthm.2014.12.014. Epub 2014 Dec 12.
Results Reference
derived
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Spinal Cord Stimulation For Heart Failure
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