EchoCRT

EchoCRT

The Echocardiography Guided Cardiac Resynchronization Therapy Clinical Investigation

Ruschitzka et al., The New England Journal of Medicine 2013

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Study Design

  • Randomized, prospective, parallel, double-blinded, multi-center, international trial
  • Evaluates the effects of CRT on mortality and morbidity of subjects with heart failure due to left ventricular systolic dysfunction with a narrow QRS width (< 130 ms) and echocardiographic evidence of ventricular dyssynchrony
  • 1,680 enrolled, 809 randomized (404 patients to CRT and 405 to control) at 115 sites in 17 countries

Disclaimer

On March 13, 2013, the study was stopped on the recommendation of the data and safety monitoring board, on the basis of futility with a potential for harm.

Key Result 1

The primary outcome, death from any cause or hospitalization for worsening heart failure, occurred in 116 of 404 patients (28.7%) in the CRT group, as compared with 102 of 405 (25.2%) in the control group (hazard ratio with CRT, 1.20; 95% confidence interval [CI], 0.92 to 1.57; P = 0.15).

Primary Composite Outcome

Key Result 2

The rate of freedom from complications related to the CRT-D system at 6 months was 89.6% for the population that included all patients who underwent an attempted implantation.1

Clinical Relevance

  • As compared with an ICD with inactivated CRT, a CRT-D did not reduce the rate of death from any cause or hospitalization for heart failure and may increase mortality among patients with systolic heart failure and a QRS duration of less than 130 msec.¹
  • Our results reinforce the notion that, at least until new methods of assessment are developed, QRS width (with or without mechanical dyssynchrony) remains the primary determinant of response to CRT.¹
Reference No.
  • NCT00683696
Study Objective
  • To evaluate the effects of Cardiac Resynchronization Therapy (CRT) on mortality and morbidity of subjects with heart failure due to left ventricular systolic dysfunction, already receiving current standard HF medication (including a diuretic), with a narrow QRS width (
1° Endpoints
  • Evaluate the effect of CRT=ON versus CRT=OFF in time to event of a combined endpoint of death or first hospitalization for worsening HF.
  • Evaluate the complication-free rate of the Lumax HF-T CRT-D system in the narrow QRS patient population at 6 months.
2° Endpoints
  • Evaluate the effects of CRT=ON compared to CRT=OFF on the rate of hospitalization for worsening heart failure.
  • Evaluate the effects of CRT=ON compared to CRT=OFF in relation to the change in NYHA classification.
  • Evaluate the effects of CRT=ON compared to CRT=OFF in relation to the change in the Minnesota Living with Heart Failure (MLHF) Quality of Life (QOL) Questionnaire.
  • Evaluate the effects of CRT=ON compared to CRT=OFF in relation to a composite endpoint of all-cause mortality, hospitalization for worsening heart failure and change in the MLHF Quality of Life Questionnaire.
  • Evaluate the all-cause mortality rate between the CRT=ON compared to CRT=OFF group.
Clinical Sites
  • 115 sites across 17 countries (United States, Canada, Israel, Australia, and Europe)
Sample Size
  • 809 randomized (404 patients to CRT and 405 to control)
Key Inclusion Criteria
  • 18 years of age or older, with New York Heart Association (NYHA) class III or IV heart failure
  • Left ventricular ejection fraction of 35% or less
  • Standard indication for an implantable cardioverter-defibrillator (ICD)
  • Stable medical therapy recommended by by current guidelines
  • QRS duration of less than 130 msec
  • Left ventricular end-diastolic diamter of 55 mm or more
  • Echocardiographic evidence of left ventricular dyssynchrony: tissue Doppler imaging opposing-wall delay in the peak systolic velocity of ≥80ms and/or speckle-tracking radial strain anteroseptal-posterior wall delay ≥130ms
Key Exclusion Criteria
  • Acute decompensated heart failure
  • Intravenous inotropic therapy
  • Atrial fibrillation within the previous month
  • Bradycardia requiring pacing
  • Details of the inclusion and exclusion criteria are povided in the Supplementary Appendix of the manuscript
Devices
  • Any BIOTRONIK CRT-D devices approved by the FDA (Lumax HF-T CRT-D)
  • Any legally marketed endocardial ICD and pacing leads
Follow-Up
  • 1-month, 3-month follow-ups, and clinical follow-up every 3 months thereafter
Study Duration
  • August 2008 - March 2013
Principal Investigators
  • Johannes Holzmeister, MD, University of Zurich, Zurich, Switzerland
  • Frank Ruschitzka, MD, University of Zurich, Zurich, Switzerland
  • William T. Abraham, MD, The Ohio State University, Columbus, OH, United States

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Open access to the publication

1 Ruschitzka F, Abraham W, Singh J, Bax J, Borer J, Brugada J, Dickstein K, Ford I, Gorcsan J III, Gras D, Krum H, Sogaard P, Holzmeister J; Cardiac-Resynchronization Therapy in Heart Failure with a Narrow QRS Complex, New England Journal of Medicine, Oct 2013;369:1395-1405