Mads Brix Kronborg

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

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DOI

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. 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. 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. Clinicaltrials.gov identifier NCT01323686. The trial was registered March 25, 2011 and the first study subject was randomized April 11, 2011.

Original languageEnglish
Article number113
JournalTrials
Volume14
ISSN1468-6708
DOIs
Publication statusPublished - 2013

Bibliographical note

Funding Information:
The study is supported by a grant from the Danish Heart Foundation (grant no. 11-04-R84-A3234-22641), the Danish Council for Independent Research (grant number 11–107461), the Central Denmark Region, Fabrikant Karl G. Andersens Foundation, and the Eva and Henry Fränkels Foundation. AS has received a fellowship grant from the Faculty of Health Sciences at Aarhus University (grant no. 2010-218/2-82). The authors would like to thank Kirsten Andersen, Sonja Runge and Bente Mortensen for their work and expertise on pacemaker programing and echocardiography, and Kirsten Ovesen, Anna-Marie Dahl Christensen and Henriette Holmberg for study coordination.

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