Spinal Cord Stimulation For Heart Failure

Systolic Heart Failure Clinical Trial

— SCS HEART  

Official title:

Spinal Cord Stimulation For Heart Failure As A Restorative Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01362725
• Other study ID #: CI-10-029-ID-SC
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: April 2011
• Est. completion date: January 2016

Study information

• Verified date: January 2019
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2016
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Systolic
• Systolic Heart Failure

Intervention

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.

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	John Hunter Hospital	New Lambton Heights	New South Wales
Hong Kong	Queen Mary Hospital	Hong Kong
Japan	Osaka University Hospital	Osaka
Japan	University of Tokyo Hospital	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

Australia,  Hong Kong,  Japan, 

References & Publications (5)

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	long-term safety	post procedural adverse events	24 months