Spinal Cord Stimulation in Heart Failure

June 7, 2017 updated by: Chang Gung Memorial Hospital

The Treatment of Spinal Cord Stimulation in Severe Heart Failure

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Morbidity and mortality in heart failure (HF) patients remain high, even with recent advances in therapies. Previous studies have shown that the autonomic nervous system plays an important role in the pathophysiology of HF and sudden cardiac death.

Spinal cord stimulation (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. The SCS system consists of an implantable pulse generator (IPG) and dual leads. 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 benefit HF patients.

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Not Applicable

Contacts and Locations

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

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

20 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  • Patient is participating in another clinical study
  • Patient is less than 20 years old
  • Patient's life's expectancy is less than 1 years as assessed by investigator

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Spinal cord stimulation
Medtronic neurostimulation system for spinal cord stimulation
Device: Medtronic neurostimulation system
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
Other Names:
  • Medtronic Restore Sensor™ Neurostimulation System
No Intervention: Control
No implantation of Medtronic neurostimulation system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite of efficacy markers
Time Frame: 6 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post procedural adverse events
Time Frame: 24 months
Post-procedure adverse events include implanted procedure related events, system related events and system modification related events.
24 months

Collaborators and Investigators

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

Sponsor

Chang Gung Memorial Hospital

Investigators

  • Principal Investigator: Chun-Li Wang, MD, Chang Gung Memorial 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 (Anticipated)

June 1, 2017

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

June 1, 2019

Study Registration Dates

First Submitted

February 17, 2017

First Submitted That Met QC Criteria

February 21, 2017

First Posted (Actual)

February 23, 2017

Study Record Updates

Last Update Posted (Actual)

June 9, 2017

Last Update Submitted That Met QC Criteria

June 7, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMRPG3G0011

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

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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