clinical evaluation on advanced resynchronization

Conditions: Heart Failure; Cardiomyopathy

Summary: 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.

Eligibility criteria:
inclusion criteria: the patient candidate for inclusion in the study must be indicated for implantation of a biventricular pacing system, with the following clinical conditions: * severe heart failure (nyha class iii or iv) * cardiomyopathy of any etiology * sinus rhythm * reduced left-ventricular ejection fraction * left-ventricular end diastolic diameter greater than or equal to 30 mm/m2 (lvedd\>30 mm/m2) * qrs duration: * \> 150 ms or * \> 120 ms and documented mechanical dissynchrony (by echo) meeting two out of three of the following criteria: * aortic pre-ejection delay \> 140 ms * interventricular mechanical delay \> 40 ms * delayed activation of postero-lateral left ventricular wall (after mitral valve opening) * optimal and stable (1 month before inclusion) pharmacological treatment, including, if tolerated, beta blockers, angiotensin-converting enzyme (ace) inhibitors or ace inhibitor substitutes, spironolactone, and diuretics exclusion criteria: any patient who has one of the following characteristics will be excluded from the study: * icd indication (life-threatening ventricular arrhythmias) * persistent or permanent atrial arrhythmia without possibility to restore sinus rhythm (spontaneous termination, anti-tachycardia pacing, pharmacological or electrical cardioversion). * patient already implanted with a conventional pacemaker device * myocardial infarction within the last three months * heart surgery, or revascularization within the last three months, or expected * heart surgery refused because of co-morbidity factors * included in transplantation list * already enrolled in other study * life expectancy less than 1 year * pregnancy * age less than 18 * forfeiture of freedom or under guardianship * not able to understand the aim of the study and its procedures * refusing to cooperate

Keywords: crt-p pea severe heart failure (nyha class iii or iv) cardiomyopathy of any etiology sinus rhythm reduced left-ventricular ejection fraction lvedd>30 mm/m2 qrs duration: > 150 ms or > 120 ms aortic pre-ejection delay > 140 ms interventricular mechanical delay > 40 ms delayed activation of postero-lateral left ventricular wall optimal and stable pharmacological treatment