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Trials
Published in: Trials 1/2013

Open Access 01-12-2013 | Study protocol

Empiric versus imaging guided left ventricular lead placement in cardiac resynchronization therapy (ImagingCRT): study protocol for a randomized controlled trial

Authors: Anders Sommer, Mads Brix Kronborg, Steen Hvitfeldt Poulsen, Morten Böttcher, Bjarne Linde Nørgaard, Kirsten Bouchelouche, Peter Thomas Mortensen, Christian Gerdes, Jens Cosedis Nielsen

Published in: Trials | Issue 1/2013

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Abstract

Background

Cardiac resynchronization therapy (CRT) is an established treatment in heart failure patients. However, a large proportion of patients remain nonresponsive to this pacing strategy. Left ventricular (LV) lead position is one of the main determinants of response to CRT. This study aims to clarify whether multimodality imaging guided LV lead placement improves clinical outcome after CRT.

Methods/Design

The ImagingCRT study is a prospective, randomized, patient- and assessor-blinded, two-armed trial. The study is designed to investigate the effect of imaging guided left ventricular lead positioning on a clinical composite primary endpoint comprising all-cause mortality, hospitalization for heart failure, or unchanged or worsened functional capacity (no improvement in New York Heart Association class and <10% improvement in six-minute-walk test). Imaging guided LV lead positioning is targeted to the latest activated non-scarred myocardial region by speckle tracking echocardiography, single-photon emission computed tomography, and cardiac computed tomography. Secondary endpoints include changes in LV dimensions, ejection fraction and dyssynchrony. A total of 192 patients are included in the study.

Discussion

Despite tremendous advances in knowledge with CRT, the proportion of patients not responding to this treatment has remained stable since the introduction of CRT. ImagingCRT is a prospective, randomized study assessing the clinical and echocardiographic effect of multimodality imaging guided LV lead placement in CRT. The results are expected to make an important contribution in the pursuit of increasing response rate to CRT.

Trial registration

Clinicaltrials.gov identifier NCT01323686. The trial was registered March 25, 2011 and the first study subject was randomized April 11, 2011.
Appendix
Available only for authorised users
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Metadata
Title
Empiric versus imaging guided left ventricular lead placement in cardiac resynchronization therapy (ImagingCRT): study protocol for a randomized controlled trial
Authors
Anders Sommer
Mads Brix Kronborg
Steen Hvitfeldt Poulsen
Morten Böttcher
Bjarne Linde Nørgaard
Kirsten Bouchelouche
Peter Thomas Mortensen
Christian Gerdes
Jens Cosedis Nielsen
Publication date
01-12-2013
Publisher
BioMed Central
Published in
Trials / Issue 1/2013
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/1745-6215-14-113

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