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

Trials

Jens Cosedis Nielsen²  Christian Gerdes²  Peter Thomas Mortensen²  Kirsten Bouchelouche¹  Bjarne Linde Nørgaard²  Morten Böttcher²  Steen Hvitfeldt Poulsen²  Mads Brix Kronborg²  Anders Sommer² 

[1]Department of Nuclear Medicine, Aarhus University Hospital, Brendstrupgaardsvej 100, Skejby DK-8200, Aarhus N, Denmark

[2]Department of Cardiology, Aarhus University Hospital, Brendstrupgaardsvej 100, Skejby DK-8200, Aarhus N, Denmark

关键词: Left ventricular lead placement;    Cardiac imaging;    Cardiac resynchronization therapy;    Heart failure;   

Others  :  1094206
DOI  :  10.1186/1745-6215-14-113

 received in 2012-08-14, accepted in 2013-04-08,  发布年份 2013

【 摘 要 】

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.

【 授权许可】

   
2013 Sommer et al.; licensee BioMed Central Ltd.

【 图 表 】

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