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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Timepoint [1] 0 0
6 months
Secondary outcome [1] 0 0
long-term safety
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
Sex
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
NA
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
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
1/04/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2016
Sample size
Target
Accrual to date
Final
20
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
Trial website
Trial related presentations / publications
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01362725