Clinical Evaluation on Advanced Resynchronization

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.

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