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

Cardiac Resynchronization Therapy Clinical Trial

— TRIPLEAD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02962791
• Other study ID #: 2016/091/HP
• Status: Recruiting
• Phase: N/A
• Start date: October 24, 2017
• Est. completion date: October 2021

Study information

• Verified date: May 2018
• Source: University Hospital, Rouen
• Contact: Frédéric ANSELME, Pr
• Phone: +3323288
• Email: frederic.anselme[@]chu-rouen.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 166
• Est. completion date: October 2021
• Est. primary completion date: October 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Resynchronization Therapy

Intervention

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
• Stimulation of 2 ventricular sites
Cardiac resynchronization therapy with stimulation of 2 ventricular sites
• Echocardiography
Standard Echocardiography will de bone for patient

Locations

Country	Name	City	State
France	Rouen University Hospital	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference from baseline in Left Ventricular End-Systolic Volume	Left Ventricular End-Systolic Volume will be evaluated using echocardiography	12 months
Secondary	Difference from baseline in left ventricular remodelling	Left ventricular remodelling will be evaluated using echocardiography	12 months
Secondary	Number of patients alive		12 months
Secondary	Number of adverse events		12 months