Clinical Evaluation on Advanced Resynchronization

Heart Failure Clinical Trial

Official title: Clinical Evaluation on Advanced Resynchronization

Status Completed

Clinical Trial 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.

Clinical Trial Description

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy
• Heart Failure

• NCT number: NCT00658203
• Study type: Interventional
• Source: LivaNova
• Status: Completed
• Phase: Phase 4
• Start date: November 2005
• Completion date: February 2008