Heart Failure
Conditions
Keywords
Heart failure, Cardiac resynchronization, Triple site ventricular pacing
Brief summary
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.
Interventions
DEVICECRT with triple site ventricular stimulation
CRT with triple site ventricular stimulation (2 RV leads and 1 LV lead)
DEVICEConventional cardiac resynchronization
Conventional cardiac resynchronization
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety of triple site CRT compared to conventional CRT | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Left ventricle remodeling | At 3 and 6 months |
| LV ejection fraction | At 3 and 6 months |
| Cardiac dyssynchrony | At 3 and 6 months |
| Feasibility of triple site CRT | 6 months |
| Exercise capacity (6 minutes hall walk test distance) | At 3 and 6 months |
| Quality of life | At 3 and 6 months |
| B-Type Natriuretic Peptide (BNP) level | 6 months |
| Functional status (clinical composite score and NYHA class) | At 3 and 6 months |
Countries
France
Outcome results
None listed