Prospective Randomized Trial Comparing TRIPLE Site ventriculAr Stimulation Versus Conventional Pacing in CRT canDidates

Study Overview
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Brief Summary
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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.

Official Title
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Prospective Randomized Trial Comparing TRIPLE Site ventriculAr Stimulation Versus Conventional Pacing in CRT canDidates: TRIPLEAD Trial

Conditions
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Cardiac Resynchronization Therapy

Intervention / Treatment
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* Procedure: Cardiac resynchronization therapy implantation
* Device: Stimulation of 3 ventricular sites
* Device: Stimulation of 2 ventricular sites
* Device: Echocardiography


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stimulation of 3 ventricular sites<br>Cardiac resynchronization therapy implantation wil be done as usual, except the additional stimulation lead. Standard Echocardiography will be done at one year | Procedure: Cardiac resynchronization therapy implantation<br>* Cardiac resynchronization therapy implantation will be done for patient with symptomatic heart failure<br>Device: Stimulation of 3 ventricular sites<br>* Cardiac resynchronization therapy with stimulation of 3 ventricular sites<br>Device: Echocardiography<br>* Standard Echocardiography will de bone for patient<br>|
| Active Comparator: Stimulation of 2 ventricular sites<br>Cardiac resynchronization therapy implantation wil be done as usual. Standard Echocardiography will be done at one year | Procedure: Cardiac resynchronization therapy implantation<br>* Cardiac resynchronization therapy implantation will be done for patient with symptomatic heart failure<br>Device: Stimulation of 2 ventricular sites<br>* Cardiac resynchronization therapy with stimulation of 2 ventricular sites<br>Device: Echocardiography<br>* Standard Echocardiography will de bone for patient<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference from baseline in Left Ventricular End-Systolic Volume | Left Ventricular End-Systolic Volume will be evaluated using echocardiography | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference from baseline in left ventricular remodelling | Left ventricular remodelling will be evaluated using echocardiography | 12 months | 
| Number of patients alive |  | 12 months | 
| Number of adverse events |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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symptomatic heart failure