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

NCT ID: NCT02962791

Last Updated: 2018-05-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 166 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-24
• Study Completion Date: 2021-10-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Cardiac resynchronization therapy implantation

Intervention Type: PROCEDURE

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

Stimulation of 3 ventricular sites

Intervention Type: DEVICE

Cardiac resynchronization therapy with stimulation of 3 ventricular sites

Echocardiography

Intervention Type: DEVICE

Standard Echocardiography will de bone for patient

Stimulation of 2 ventricular sites

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

Group Type: ACTIVE_COMPARATOR

Cardiac resynchronization therapy implantation

Intervention Type: PROCEDURE

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

Stimulation of 2 ventricular sites

Intervention Type: DEVICE

Cardiac resynchronization therapy with stimulation of 2 ventricular sites

Echocardiography

Intervention Type: DEVICE

Standard Echocardiography will de bone for patient

Interventions

Cardiac resynchronization therapy implantation

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

Intervention Type: PROCEDURE

Stimulation of 3 ventricular sites

Cardiac resynchronization therapy with stimulation of 3 ventricular sites

Intervention Type: DEVICE

Stimulation of 2 ventricular sites

Cardiac resynchronization therapy with stimulation of 2 ventricular sites

Intervention Type: DEVICE

Echocardiography

Standard Echocardiography will de bone for patient

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Rouen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frédéric ANSELME, Pr

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Rouen

Locations

Rouen University Hospital

Rouen, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Frédéric ANSELME, Pr

Role: CONTACT

frederic.anselme@chu-rouen.fr

+3323288 ext. 8265

Julien BLOT

Role: CONTACT

julien.blot@chu-rouen.fr

Facility Contacts

Frédéric ANSELME, Pr

Role: primary

Other Identifiers

2016/091/HP

Identifier Type: -

Identifier Source: org_study_id