Spinal Cord Stimulation in Heart Failure

Not Applicable

• Conditions: Heart Failure
• Interventions: Device: Medtronic neurostimulation system

• Registration Number: NCT03060148
• Lead Sponsor: Chang Gung Memorial Hospital

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).

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 Timeline

• Study First Submitted: 2017-02-17
• Study First Submitted QC: 2017-02-21
• Study First Posted: 2017-02-23
• Status Verified: 2017-03
• Study Start: 2017-06
• Last Update Submitted: 2017-06-07
• Last Update Posted: 2017-06-09
• Primary Completion: 2018-12
• Study Completion: 2019-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Spinal cord stimulation	Medtronic neurostimulation system	Medtronic neurostimulation system for spinal cord stimulation

Primary Outcome Measures

Name	Time	Method
Composite of efficacy markers	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.

Secondary Outcome Measures

Name	Time	Method
Post procedural adverse events	24 months	Post-procedure adverse events include implanted procedure related events, system related events and system modification related events.