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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
implantation of Eon Mini Neurostimulation System (IPG Model 3788)
CHU
Pessac, France
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.
Time frame: 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.
Time frame: 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.
Time frame: baseline to 6 months
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.
Time frame: 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.
Time frame: 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.
Time frame: baseline and 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
Time frame: baseline and 6 months