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

Abbott

Status

Withdrawn

Conditions

Heart Failure

Treatments

Device: St Jude Medical EON mini rechargeable system

Study type

Interventional

Funder types

Industry

Identifiers

NCT01820130

CR-12-047-FR-SC

Details and patient eligibility

About

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).

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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