Trial of Autonomic neuroModulation for trEatment of Chronic Heart Failure

NCT01820130 | Withdrawn DMC

• 1 other identifier: CR-12-047-FR-SC
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this clinical investigation is to evaluate the safety and efficacy of Spinal Cord Stimulation (SCS) in advanced heart failure (HF) patients with Implantable Cardioverter Defibrillator (ICD) but not indicated for Cardiac Resynchronization Therapy (CRT).

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (3)

• Efficacy Marker of Cardiac remodeling via Left Ventricular End Diastolic Volume (LVEDV) of Patient with advanced HF

  Evaluation of left ventricular end diastolic volume (LVEDV) as measured by cardiac echo between baseline and after 6 months of SCS therapy.

  baseline and 6 Months

• Efficacy Marker of patient symptom via NYHA class for patient with advanced HF

  Evaluation of NYHA class as marker of patient symptom between baseline and after 6 months of SCS therapy.

  Baseline and 6 months

• Efficacy Marker of patient symptom via 6 Minutes Hall Walk distance for patient with advanced HF

  Evaluation of 6 Minutes Hall walk (6MHW) as marker of patient symptom between baseline and after 6 months of SCS therapy.

  baseline to 6 months

Secondary Outcomes (4)

• Safety composite marker of SCS therapy for patient with HF and ICD device

  baseline and 6 months

• Additional efficacy markers of SCS therapy on patient symptom via Quality Of Life questionnaire

  baseline to 6 months

• Additional efficacy markers of SCS therapy on patient symptom via Maximal exercise test tolerance

  baseline and 6 months

• Additional efficacy markers of SCS therapy on cardiac function via echocardiography

  baseline and 6 months

Study Arms (1)

Spinal Cord Stimulation system therapy

EXPERIMENTAL

St Jude Medical EON mini rechargeable system

Device: St Jude Medical EON mini rechargeable system

Interventions

St Jude Medical EON mini rechargeable system DEVICE

implantation of Eon Mini Neurostimulation System (IPG Model 3788)

Also known as: Eon Mini Neurostimulation System (IPG Model 3788)

Spinal Cord Stimulation system therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients has a Left Ventricular Ejection Fraction (LVEF) less than or equal to 35%
• Patient is in New York Heart Association (NYHA) Class III
• Patient has had an ICD implanted for \>90 days
• Patient is receiving stable and optimal medical therapy for HF (\>90 days) as describe by "European Society of Cardiology 2012 recommendation for diagnosis and treatment of acute and chronic Heart Failure", except in case of contraindication or allergy
• Patient is able to provide written Informed Consent prior to any investigational related procedure

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 or has had previous spinal surgery that would interfere with implant of percutaneous SCS leads in the upper thoracic region
• Patient has polyneuropathy
• Patient requires short-wave diathermy, microwave diathermy or therapeutic ultrasound diathermy
• Patient is in NYHA class IV
• Patient has received a tissue / organ transplant or is expected to have a tissue / organ transplant within the next 180 days
• Patient has a cardiac resynchronization therapy (CRT) device, or LV Assist device or is expected to receive CRT, or left ventricular assist device (LVAD) within the next 180 days
• 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) within 90 days of enrollment
• 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 (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)

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (1)

CHU

Pessac, 33604, France

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Pierre Bordachar, MD

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2013
• First Posted: March 28, 2013
• Study Start: March 1, 2013
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: February 4, 2019

Record last verified: 2019-02

Locations

FR (1)