Clinical Evaluation on Advanced Resynchronization

Clinical Evaluation on Advanced Resynchronization

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.

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