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

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

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.

Study Overview

• Status: Terminated
• Conditions: Cardiac Resynchronization Therapy
• Intervention / Treatment: Procedure: Cardiac resynchronization therapy implantation; Device: Stimulation of 3 ventricular sites; Device: Echocardiography; Device: Stimulation of 2 ventricular sites

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Rouen, France
    • Rouen University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Procedure: Cardiac resynchronization therapy implantation; Cardiac resynchronization therapy implantation will be done for patient with symptomatic heart failure; Device: Stimulation of 3 ventricular sites; Cardiac resynchronization therapy with stimulation of 3 ventricular sites; Device: Echocardiography; Standard Echocardiography will de bone for patient
Active Comparator: Stimulation of 2 ventricular sites; Cardiac resynchronization therapy implantation wil be done as usual. Standard Echocardiography will be done at one year	Procedure: Cardiac resynchronization therapy implantation; Cardiac resynchronization therapy implantation will be done for patient with symptomatic heart failure; Device: Echocardiography; Standard Echocardiography will de bone for patient; Device: Stimulation of 2 ventricular sites; Cardiac resynchronization therapy with stimulation of 2 ventricular sites

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Rouen
• Investigators: Principal Investigator: Frédéric ANSELME, Pr, University Hospital, Rouen

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2017
• Primary Completion (Actual): November 20, 2020
• Study Completion (Actual): November 20, 2020

Study Registration Dates

• First Submitted: November 9, 2016
• First Submitted That Met QC Criteria: November 9, 2016
• First Posted (Estimated): November 11, 2016

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 24, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: symptomatic heart failure
• Additional Relevant MeSH Terms: Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Imaging; Diagnostic Techniques, Cardiovascular; Heart Function Tests; Cardiac Imaging Techniques; Ultrasonography; Echocardiography
• Other Study ID Numbers: 2016/091/HP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No