NCT00658203

Clinical Evaluation on Advanced Resynchronization

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 310 (estimated)
• Sponsor: LivaNova · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Heart Failure
• Cardiomyopathy

Interventions

Type	Name	Description
DEVICE	New Living CHF	PEA CRT optimization
DEVICE	New Living CHF	Standard optimized CRT.

Timeline

• Start date: 2005-11-01
• Primary completion: 2008-02-01
• Completion: 2008-02-01
• First posted: 2008-04-14
• Last updated: 2008-04-14

Locations

36 sites across 6 countries: France, Germany, Italy, Netherlands, Spain, United Kingdom