Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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