The aim of the study is to compare clinical benefits of the cardiac resynchronisation (CRT) achieved by the PEA optimised pacing configuration and a CRT optimised by standard clinical procedure. PEA optimised configuration (PEA-CRT) is obtained, during patient's follow-up, using the Peak Endocardial Acceleration sensor features onboard the device.
The study is a prospective, multicentre, controlled and randomised clinical investigation, with two single-blinded arms. The objective of the study is to compare the clinical benefits of Cardiac Resynchronisation Therapy (CRT) optimised by automatic PEA sensor features (PEA-CRT), with those obtained by standard optimisation procedure (STD-CRT). The patient candidate for inclusion in the study has a severe chronic Heart Failure, indicated for the implantation of a Biventricular pacing system according to updated ESC guidelines (2005). All patients included in the study will be followed-up for 1 year; patient's follow-ups are scheduled during hospitalisation, at one month, 3 months, 6 months and one year after implantation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
310
PEA CRT optimization
Standard optimized CRT.
CH Albi
The primary endpoint will be evaluated at 1 year (M12), in term of improved, unchanged or worsened patient's conditions, with a composite analysis of NYHA class evolution, heart-failure-related hospitalisations and Quality of Life evaluation.
Time frame: 12 months
PEA-CRT optimisation is at least effective as the standard optimisation in term of efficacy of the therapy and patients' quality of life.
Time frame: 12 months
PEA is an index of the patients' clinical status and allows to predict acute HF episode in both arms.
Time frame: 12 months
Efficacy of the therapy comparing the two arms in terms of NYHA
Time frame: 12 months
Efficacy of the therapy comparing the two arms in terms of Cardiovascular mortality
Time frame: 12 months
Efficacy of the therapy comparing the two arms in terms of Heart Failure Quality Of Life (EuroQoL-5D) score
Time frame: 12 months
Efficacy of the therapy comparing the two arms in terms of BNP dosage
Time frame: 12 months
Efficacy of the therapy comparing the two arms in terms of Number and duration of heart-failure-related patient's hospitalisations, during the study period.
Time frame: 12 months
Efficacy of the therapy comparing the two arms in terms of Left Ventricular End Diastolic Diameter
Time frame: 12 months
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Albi, France
CHU Angers
Angers, France
CHU Bordeaux
Bordeaux, France
CH Lomme
Lomme, France
CHU Montpellier
Montpellier, France
NC Nantaises
Nantes, France
CH Pau
Pau, France
CHU Poitiers
Poitiers, France
CHR Cardiologie A
Rennes, France
CHU Rouen
Rouen, France
...and 26 more locations
Efficacy of the therapy comparing the two arms in terms of Left Ventricular End Systolic Diameter
Time frame: 12 months
Efficacy of the therapy comparing the two arms in terms of Left Ventricular Ejection Fraction
Time frame: 12 months
Efficacy of the therapy comparing the two arms in terms of Left Pre-Ejection Interval
Time frame: 12 months
Efficacy of the therapy comparing the two arms in terms of Right Pre-Ejection Interval
Time frame: 12 months
Efficacy of the therapy comparing the two arms in terms of Total Duration of Left Systole
Time frame: 12 months
Efficacy of the therapy comparing the two arms in terms of E velocity
Time frame: 12 months
Efficacy of the therapy comparing the two arms in terms of A velocity
Time frame: 12 months
Efficacy of the therapy comparing the two arms in terms of Ventricular spike-Mitral valve closure interval
Time frame: 12 months
Efficacy of the therapy comparing the two arms in terms of Ventricular spike-Mitral valve opening interval
Time frame: 12 months
Efficacy of the therapy comparing the two arms in terms of Mitral Valve regurgitation.
Time frame: 12 months
Time spent to achieve the CRT optimal configuration during each follow-up
Time frame: 12 months
PEA monitoring and prognostic relevance correlating the PEA diagnostic trends with the parameters used to asses the efficacy of the therapy and patients' quality of life (NYHA class, mortality, HF-hospitalisation, EuroQoL-5D score, BNP dosage, Echo
Time frame: 12 months
(LVEF) comparing the changes Left Ventricular Ejection Fraction in the two arms with an intermediate analysis at 6 months done by a Core Centre.
Time frame: 6 and 12 months