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

Not Applicable

• Conditions: Cardiac Resynchronization Therapy
• Interventions: Procedure: Cardiac resynchronization therapy implantation; Device: Stimulation of 3 ventricular sites; Device: Stimulation of 2 ventricular sites; Device: Echocardiography

• Registration Number: NCT02962791
• Lead Sponsor: University Hospital, Rouen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-11-09
• Study First Submitted QC: 2016-11-09
• Study First Posted: 2016-11-11
• Study Start: 2017-10-24
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-25
• Last Update Posted: 2018-05-30
• Primary Completion: 2021-10
• Study Completion: 2021-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 166

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stimulation of 3 ventricular sites	Stimulation of 3 ventricular sites	Cardiac resynchronization therapy implantation wil be done as usual, except the additional stimulation lead. Standard Echocardiography will be done at one year
Stimulation of 3 ventricular sites	Echocardiography	Cardiac resynchronization therapy implantation wil be done as usual, except the additional stimulation lead. Standard Echocardiography will be done at one year
Stimulation of 2 ventricular sites	Cardiac resynchronization therapy implantation	Cardiac resynchronization therapy implantation wil be done as usual. Standard Echocardiography will be done at one year
Stimulation of 2 ventricular sites	Echocardiography	Cardiac resynchronization therapy implantation wil be done as usual. Standard Echocardiography will be done at one year
Stimulation of 3 ventricular sites	Cardiac resynchronization therapy implantation	Cardiac resynchronization therapy implantation wil be done as usual, except the additional stimulation lead. Standard Echocardiography will be done at one year
Stimulation of 2 ventricular sites	Stimulation of 2 ventricular sites	Cardiac resynchronization therapy implantation wil be done as usual. Standard Echocardiography will be done at one year

Primary Outcome Measures

Name	Time	Method
Difference from baseline in Left Ventricular End-Systolic Volume	12 months	Left Ventricular End-Systolic Volume will be evaluated using echocardiography

Secondary Outcome Measures

Name	Time	Method
Number of patients alive	12 months
Difference from baseline in left ventricular remodelling	12 months	Left ventricular remodelling will be evaluated using echocardiography
Number of adverse events	12 months

Trial Locations

Locations (1)

Rouen University Hospital; 🇫🇷 Rouen, France