Spinal Cord Stimulation For Heart Failure (SCS HEART)

January 31, 2019 updated by: Abbott Medical Devices

Spinal Cord Stimulation For Heart Failure As A Restorative Treatment

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • New Lambton Heights, New South Wales, Australia, 2305
        • John Hunter Hospital
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Royal Adelaide Hospital
  • Hong Kong
      • Hong Kong, Hong Kong
        • Queen Mary Hospital
  • Japan
      • Osaka, Japan
        • Osaka University Hospital
      • Tokyo, Japan
        • University of Tokyo Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
long-term safety
Time Frame: 24 months
post procedural adverse events
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Investigators

  • Principal Investigator: Hung-Fat Tse, MD, The University of Hong Kong, Queen Mary Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

May 26, 2011

First Submitted That Met QC Criteria

May 27, 2011

First Posted (Estimate)

May 30, 2011

Study Record Updates

Last Update Posted (Actual)

February 4, 2019

Last Update Submitted That Met QC Criteria

January 31, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CI-10-029-ID-SC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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