Triple Site Ventricular Stimulation for Cardiac Resynchronization Therapy (CRT) Candidates (TRIV)

Medtronic

Status and phase

Completed

Phase 3

Conditions

Heart Failure

Treatments

Device: CRT with triple site ventricular stimulation

Device: Conventional cardiac resynchronization

Study type

Interventional

Funder types

Industry

Identifiers

NCT00887237

TRIV

Details and patient eligibility

About

Despite technological progresses the rate of non-responders to cardiac resynchronization therapy (CRT) remains close to 30%. This inconsistent effect of CRT might be due to incomplete resynchronization as dyssynchrony can persist in 25% to 30% of patients during CRT.

One might hypothesize that stimulating the ventricles at a single site is suboptimal and that stimulating multiple left ventricular (LV) or right ventricular (RV) sites may improve ventricular resynchronization and, consequently, its hemodynamic and clinical effects. First studies have suggested that 1 RV + 2 LV pacing sites configurations increased significantly dP/dt, pulse pressure, LV end-diastolic pressure, and is associated with more LV remodeling and better responder rate compared with pacing a single LV site. First studies with 2 RV+LV pacing sites configuration demonstrated increased dP/dt and cardiac output and a decrease of the cardiac dyssynchrony.

The present pilot trial was designed to examine the 6-month safety of biventricular stimulation with 2 right ventricular (RV) and 1 left ventricular (LV) leads - main objective- and to assess its clinical benefit.

Enrollment

76 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Signed informed consent
> 18 years old
Cardiac resynchronization indication : New York Heart Association (NYHA) Class III/IV & QRS width > 120 ms milliseconds (ms) OR NYHA class II & QRS width > 150 ms
Sinus rhythm
First implant procedure

Exclusion criteria

Permanent ventricular tachycardia
Permanent pacing indication for 3rd degree atrioventricular (AV) block
Diagnosed or suspected acute myocarditis
Less than 1 year life expectancy related to a non-cardiovascular disease
Impossibility to perform follow-up in the investigative center
Pregnant woman
Patient which may not cooperate to study procedures as evaluated by investigator
Legally protected adult patient or patient unable to give an informed consent
Patient enrolled in an other clinical trial
Patient which does not benefit from a social protection system
Renal insufficiency
Patient registered on a heart transplant waiting list
Disease and/or health condition which may interfere with study results