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

Trials. 2013 Apr 26:14:113. doi: 10.1186/1745-6215-14-113.

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.

Publication types

  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Cardiac Resynchronization Therapy / adverse effects
  • Cardiac Resynchronization Therapy / methods*
  • Cardiac Resynchronization Therapy / mortality
  • Cardiac Resynchronization Therapy Devices
  • Clinical Protocols
  • Denmark
  • Diagnostic Imaging / methods
  • Disease Progression
  • Double-Blind Method
  • Echocardiography, Doppler
  • Exercise Test
  • Exercise Tolerance
  • Heart Failure / diagnosis
  • Heart Failure / mortality
  • Heart Failure / physiopathology
  • Heart Failure / therapy*
  • Hospitalization
  • Humans
  • Predictive Value of Tests
  • Prospective Studies
  • Recovery of Function
  • Research Design*
  • Stroke Volume
  • Therapy, Computer-Assisted / instrumentation
  • Therapy, Computer-Assisted / methods*
  • Time Factors
  • Tomography, Emission-Computed, Single-Photon
  • Tomography, X-Ray Computed
  • Treatment Outcome
  • Ventricular Dysfunction, Left / diagnosis
  • Ventricular Dysfunction, Left / mortality
  • Ventricular Dysfunction, Left / physiopathology
  • Ventricular Dysfunction, Left / therapy*
  • Ventricular Function, Left*

Associated data

  • ClinicalTrials.gov/NCT01323686