Cardiac Resynchronization Therapy
Conditions
Keywords
symptomatic heart failure
Brief summary
Cardiac resynchronization therapy (CRT) is a recommended treatment for selected patients with symptomatic heart failure (HF). Although most treated patients show a benefit from CRT, a lack of response is observed for about 25-30% of them whatever the response criteria used either based on the clinical status (NYHA class, Packer clinical composite score) or on ventricular remodeling parameters assessed by echography (Left ventricle end of systole volume). This rate has remained remarkably stable since the therapy started and has motivated many studies to better understand the underlying physiopathology and the CRT action mechanisms. Among the various research axes to improve CRT response and responders rate, increasing the number of pacing sites in an attempt to better homogenize the cardiac mechanical activity has been evaluated. A configuration with two RV leads and one LV lead was tested acutely in three studies. In all cases, it demonstrated a significant improvement of cardiac performance whether assessed by echographic parameters or LV dp/dt measurements. Additionally feasibility of this approach for long term CRT delivery was demonstrated during a previous study. First results with triple-site ventricular stimulation are encouraging and its clinical efficacy should now be tested on a larger population in order to conclude on its interest for CRT candidates.
Interventions
PROCEDURECardiac resynchronization therapy implantation
Cardiac resynchronization therapy implantation will be done for patient with symptomatic heart failure
DEVICEStimulation of 3 ventricular sites
Cardiac resynchronization therapy with stimulation of 3 ventricular sites
DEVICEStimulation of 2 ventricular sites
Cardiac resynchronization therapy with stimulation of 2 ventricular sites
DEVICEEchocardiography
Standard Echocardiography will de bone for patient
Sponsors
University Hospital, Rouen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient who signed the MEC approved informed consent * Patient older than 18 * Patient with a CRT (CRT-P or D) indication as per ESC guidelines 2013 * Left Ventricular Ejection Fraction (LVEF) ≤ 35% * NYHA class II/III/IV despite optimal medical treatment * Left Bundle Branch Block (LBBB) and QRS ≥ 120 ms (class IA and IB indications) or in the absence of LBBB QRS \> 150 ms (class IIA indication) * De novo implantation * Sinus rhythm
Exclusion criteria
* Permanent supra ventricular tachycardia * Pacing indication for 3rd degree AV block * Impossibility to perform FU at the investigative center * Pregnancy * Adults under legal protection * Heart transplant candidates * Concomitant pathology that may interfere with the study results
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference from baseline in Left Ventricular End-Systolic Volume | 12 months | Left Ventricular End-Systolic Volume will be evaluated using echocardiography |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference from baseline in left ventricular remodelling | 12 months | Left ventricular remodelling will be evaluated using echocardiography |
| Number of patients alive | 12 months | — |
| Number of adverse events | 12 months | — |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORFrédéric ANSELME, Pr
University Hospital, Rouen
Outcome results
None listed