Clinical trial NCT02962791: Prospective Randomized Trial Comparing TRIPLE Site ventriculAr Stimulation Versus Conventional Pacing in CRT canDidates
Official title: Prospective Randomized Trial Comparing TRIPLE Site ventriculAr Stimulation Versus Conventional Pacing in CRT canDidates: TRIPLEAD Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiac Resynchronization Therapy
Keywords: symptomatic heart failure
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2016-11-11
Enrollment: 166
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Difference from baseline in Left Ventricular End-Systolic Volume
timeFrame: 12 months
Secondary outcomes:
measure: Difference from baseline in left ventricular remodelling
timeFrame: 12 months
measure: Number of patients alive
timeFrame: 12 months
measure: Number of adverse events
timeFrame: 12 months
Other outcomes:
Locations:
city: Rouen
country: France
facility: Rouen University Hospital
Study officials:
affiliation: University Hospital, Rouen
name: Frédéric ANSELME, Pr
role: PRINCIPAL_INVESTIGATOR
References: