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

NCT02962791 | Terminated DMC

• 1 other identifier: 2016/091/HP
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Resynchronization Therapy

Keywords

symptomatic heart failure

Outcome Measures

Primary Outcomes (1)

• Difference from baseline in Left Ventricular End-Systolic Volume

  Left Ventricular End-Systolic Volume will be evaluated using echocardiography

  12 months

Secondary Outcomes (3)

• Difference from baseline in left ventricular remodelling

  12 months

• Number of patients alive

  12 months

• Number of adverse events

  12 months

Study Arms (2)

Stimulation of 3 ventricular sites

EXPERIMENTAL

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; Device: Stimulation of 3 ventricular sites; Device: Echocardiography

Stimulation of 2 ventricular sites

ACTIVE COMPARATOR

Cardiac resynchronization therapy implantation wil be done as usual. Standard Echocardiography will be done at one year

Procedure: Cardiac resynchronization therapy implantation; Device: Stimulation of 2 ventricular sites; Device: Echocardiography

Interventions

Cardiac resynchronization therapy implantation PROCEDURE

Cardiac resynchronization therapy implantation will be done for patient with symptomatic heart failure

Stimulation of 2 ventricular sites; Stimulation of 3 ventricular sites

Stimulation of 3 ventricular sites DEVICE

Cardiac resynchronization therapy with stimulation of 3 ventricular sites

Stimulation of 3 ventricular sites

Stimulation of 2 ventricular sites DEVICE

Cardiac resynchronization therapy with stimulation of 2 ventricular sites

Stimulation of 2 ventricular sites

Echocardiography DEVICE

Standard Echocardiography will de bone for patient

Stimulation of 2 ventricular sites; Stimulation of 3 ventricular sites

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

Rouen University Hospital

Rouen, France

Location

MeSH Terms

Interventions

Echocardiography

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Officials

• Frédéric ANSELME, Pr

  University Hospital, Rouen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2016
• First Posted: November 11, 2016
• Study Start: October 24, 2017
• Primary Completion: November 20, 2020
• Study Completion: November 20, 2020
• Last Updated: April 29, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)