NCT01362725

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 Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 2011

Longer than P75 for phase_2

Geographic Reach
3 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 26, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 30, 2011

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

February 4, 2019

Status Verified

January 1, 2019

Enrollment Period

3.3 years

First QC Date

May 26, 2011

Last Update Submit

January 31, 2019

Conditions

Systolic Heart Failure

Keywords

spinal cord stimulationsystolic heart failure

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 months

Secondary Outcomes (1)

  • long-term safety

    24 months

Study Arms (1)

Spinal cord stimulation

EXPERIMENTAL
Device: Spinal cord stimulation system

Interventions

Spinal cord stimulation systemDEVICE

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.

Also known as: 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.
Spinal cord stimulation

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

John Hunter Hospital

New Lambton Heights, New South Wales, 2305, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Queen Mary Hospital

Hong Kong, Hong Kong

Location

Osaka University Hospital

Osaka, Japan

Location

University of Tokyo Hospital

Tokyo, Japan

Location

Related Publications (6)

  • 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.

    PMID: 19597055BACKGROUND

  • 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.

    PMID: 10946073BACKGROUND

  • 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.

    PMID: 11873770BACKGROUND

  • Deer TR, Raso LJ. Spinal cord stimulation for refractory angina pectoris and peripheral vascular disease. Pain Physician. 2006 Oct;9(4):347-52.

    PMID: 17066119BACKGROUND

  • 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.

    PMID: 3871177BACKGROUND

  • 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.

    PMID: 25500165DERIVED

MeSH Terms

Conditions

Heart Failure, Systolic

Condition Hierarchy (Ancestors)

Heart FailureHeart DiseasesCardiovascular Diseases

Study Officials

  • Hung-Fat Tse, MD

    The University of Hong Kong, Queen Mary Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2011

First Posted

May 30, 2011

Study Start

April 1, 2011

Primary Completion

August 1, 2014

Study Completion

January 1, 2016

Last Updated

February 4, 2019

Record last verified: 2019-01

Locations

AU(2)HK(1)JP(2)