NCT02962791: TRIPLEAD

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

Completed NA Last updated 6 February 2026

What this trial tests

NA trial testing Cardiac resynchronization therapy implantation in Cardiac Resynchronization Therapy in 36 participants. Completed in 20 November 2020.

Timeline

24 October 2017

Primary endpoint
20 November 2020

20 November 2020

Quick facts

Lead sponsor	University Hospital, Rouen
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	36
Start date	24 October 2017
Primary completion	20 November 2020
Estimated completion	20 November 2020
Sites	1 location across France

Drugs / interventions tested

• Cardiac resynchronization therapy implantation
• Stimulation of 3 ventricular sites
• Stimulation of 2 ventricular sites
• Echocardiography

Conditions studied

• Cardiac Resynchronization Therapy — all drugs for Cardiac Resynchronization Therapy →

Sponsor

University Hospital, Rouen

Who can join

18 and older, any sex, with Cardiac Resynchronization Therapy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.