Trial of Autonomic neuroModulation for trEatment of Chronic Heart Failure (TAME-HF)

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).

Study Overview

• Status: Withdrawn
• Conditions: Heart Failure
• Intervention / Treatment: Device: St Jude Medical EON mini rechargeable system

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Pessac, France, 33604
    • CHU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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 a QRS duration <120 ms (non-paced QRS, at the time of device Implant or protocol inclusion)
• 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

Exclusion Criteria:

• 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)
• Patient with risk of allergy to SCS device component materials

• Patient having one of the following condition must be considered as non relevant for SCS implantation:

  1. / Patient with active stent
  2. / Patient having bare metal stent for less than 6 months
  3. / Patient presented with an acute coronary syndrome within the last 6 months
  4. / Patient with stent on the common
  5. / Patient with a history of stent thrombosis
  6. / Coronary Patient receiving double antiplatelet medication
• Patient is participating in another clinical study with an active treatment arm
• Patient is less than 18 years old
• Patient's life's expectancy is less than 1 year as assessed by investigators

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Spinal Cord Stimulation system therapy; St Jude Medical EON mini rechargeable system	Device: St Jude Medical EON mini rechargeable system; implantation of Eon Mini Neurostimulation System (IPG Model 3788); Other Names: Eon Mini Neurostimulation System (IPG Model 3788)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety composite marker of SCS therapy for patient with HF and ICD device	Report of cardiovascular event, arrythmias, devices interaction, procedural and post-procedural events analyzed in a global composite way.	baseline and 6 months
Additional efficacy markers of SCS therapy on patient symptom via Quality Of Life questionnaire	Endpoint measurements of patient-reported quality of life after 6 months of therapy.	baseline to 6 months
Additional efficacy markers of SCS therapy on patient symptom via Maximal exercise test tolerance	Additional endpoint measurements include exercise tolerance between baseline and 6 months via cardiopulmonary test, including maximum level of exercise and heart rhythm.	baseline and 6 months
Additional efficacy markers of SCS therapy on cardiac function via echocardiography	Additional endpoint measurements include standard echocardiography markers of LV structure and function including systolic and diastolic performance and cardiac dimensions as a marker of structural reverse remodeling	baseline and 6 months

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Principal Investigator: Pierre Bordachar, MD, University Hospital, Bordeaux

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Anticipated): September 1, 2016
• Study Completion (Anticipated): September 1, 2016

Study Registration Dates

• First Submitted: February 22, 2013
• First Submitted That Met QC Criteria: March 25, 2013
• First Posted (Estimate): March 28, 2013

Study Record Updates

• Last Update Posted (Actual): February 4, 2019
• Last Update Submitted That Met QC Criteria: February 1, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: CR-12-047-FR-SC