NCT03060148

Brief Summary

Previous studies have shown that spinal cord stimulation (SCS) may improve cardiac output and decrease the risk of ischemic ventricular arrhythmia in animal model and its safety profile in human trial. The purposes of this study are to evaluate the feasibility, treatment efficacy and safety of SCS in patients with severe symptomatic heart failure (HF).

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable heart-failure

Timeline
Completed

Started Jun 2017

Status
unknown

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

First Submitted

Initial submission to the registry

February 17, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 23, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

June 9, 2017

Status Verified

March 1, 2017

Enrollment Period

1.5 years

First QC Date

February 17, 2017

Last Update Submit

June 7, 2017

Conditions

Heart Failure

Keywords

Heart failureSpinal cord stimulation

Outcome Measures

Primary Outcomes (1)

  • Composite of efficacy markers

    Efficacy markers include peak oxygen uptake, New York Heart Association functional class, left ventricular structure and function (left ventricular end-systolic volume and ejection fraction), B-type natriuretic peptide, Minnesota Living with Heart Failure Questionnaire score: Improvement: +1; no change:0; worsening: -1.

    6 months

Secondary Outcomes (1)

  • Post procedural adverse events

    24 months

Study Arms (2)

Spinal cord stimulation

ACTIVE COMPARATOR

Medtronic neurostimulation system for spinal cord stimulation

Device: Medtronic neurostimulation system

Control

NO INTERVENTION

No implantation of Medtronic neurostimulation system

Interventions

Medtronic neurostimulation systemDEVICE

Dual leads for spinal cord stimulation will be performed at 90% of the motor threshold for 24 hours/day at 50 Hz and pulse width 0.2 ms

Also known as: Medtronic Restore Sensorâ„¢ Neurostimulation System
Spinal cord stimulation

Eligibility Criteria

Age20 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients has a left ventricular ejection fraction between 20% and 35%
  • Patient is in New York Heart Association Class III or in Ambulatory Class IV
  • Patient is receiving stable medical therapy for HF (\>90 days) at baseline
  • Patient has a left ventricular end diastolic diameter between 55 mm and 80 mm
  • 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 upper thoracic 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
  • 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 \>1.2 and platelet count \<100 x10\^9 per liter)
  • Patient has a local infection at the implantable cardioverter-defibrillator (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

Related Publications (4)

  • Zipes DP, Neuzil P, Theres H, Caraway D, Mann DL, Mannheimer C, Van Buren P, Linde C, Linderoth B, Kueffer F, Sarazin SA, DeJongste MJL; DEFEAT-HF Trial Investigators. Determining the Feasibility of Spinal Cord Neuromodulation for the Treatment of Chronic Systolic Heart Failure: The DEFEAT-HF Study. JACC Heart Fail. 2016 Feb;4(2):129-136. doi: 10.1016/j.jchf.2015.10.006. Epub 2015 Dec 9.

    PMID: 26682789BACKGROUND

  • 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: 25500165BACKGROUND

  • 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

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Chun-Li Wang, MD

    Chang Gung Memorial Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chun-Li Wang, MD

CONTACT

+886975368158wang3015@cgmh.org.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Medtronic neurostimulation
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2017

First Posted

February 23, 2017

Study Start

June 1, 2017

Primary Completion

December 1, 2018

Study Completion

June 1, 2019

Last Updated

June 9, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share