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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01362725




Registration number
NCT01362725
Ethics application status
Date submitted
26/05/2011
Date registered
30/05/2011
Date last updated
4/02/2019

Titles & IDs
Public title
Spinal Cord Stimulation For Heart Failure
Scientific title
Spinal Cord Stimulation For Heart Failure As A Restorative Treatment
Secondary ID [1] 0 0
CI-10-029-ID-SC
Universal Trial Number (UTN)
Trial acronym
SCS HEART
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Systolic Heart Failure 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Spinal cord stimulation system

Experimental: Spinal cord stimulation -


Treatment: Devices: 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.

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
6 months
Secondary outcome [1] 0 0
long-term safety - post procedural adverse events
Timepoint [1] 0 0
24 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
95 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2/Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA
Recruitment hospital [1] 0 0
John Hunter Hospital - New Lambton Heights
Recruitment hospital [2] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 0 0
2305 - New Lambton Heights
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment outside Australia
Country [1] 0 0
Hong Kong
State/province [1] 0 0
Hong Kong
Country [2] 0 0
Japan
State/province [2] 0 0
Osaka
Country [3] 0 0
Japan
State/province [3] 0 0
Tokyo

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Abbott Medical Devices
Address
Country

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/show/NCT01362725
Trial related presentations / publications
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.
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.
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.
Deer TR, Raso LJ. Spinal cord stimulation for refractory angina pectoris and peripheral vascular disease. Pain Physician. 2006 Oct;9(4):347-52. Review.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Hung-Fat Tse, MD
Address 0 0
The University of Hong Kong, Queen Mary Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications