TerminatedNot Applicable

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

Stopped: Difficulty in resuming inclusions following the COVID-19 crises

France36 participantsStarted 2017-10-24

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Difference from baseline in Left Ventricular End-Systolic Volume

Timeframe: 12 months

Trial details

NCT IDNCT02962791

SponsorUniversity Hospital, Rouen

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-11-20

View on ClinicalTrials.gov More Cardiac Resynchronization Therapy trials