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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
76
CRT with triple site ventricular stimulation (2 RV leads and 1 LV lead)
Conventional cardiac resynchronization
University hospital of Bordeaux
Bordeaux, France
University hospital of Lille
Lille, France
University hospital La Timone
Marseille, France
University hospital of Montpellier
Montpellier, France
University hospital of Nancy
Nancy, France
Nouvelles Cliniques Nantaises
Nantes, France
University hospital of Nantes
Nantes, France
Clinique Bizet
Paris, France
University Hospital of Rennes
Rennes, France
University hospital of Rouen
Rouen, France
...and 2 more locations
Safety of triple site CRT compared to conventional CRT
Time frame: 6 months
Feasibility of triple site CRT
Time frame: 6 months
Left ventricle remodeling
Time frame: At 3 and 6 months
LV ejection fraction
Time frame: At 3 and 6 months
Cardiac dyssynchrony
Time frame: At 3 and 6 months
Functional status (clinical composite score and NYHA class)
Time frame: At 3 and 6 months
Exercise capacity (6 minutes hall walk test distance)
Time frame: At 3 and 6 months
Quality of life
Time frame: At 3 and 6 months
B-Type Natriuretic Peptide (BNP) level
Time frame: 6 months
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