The Echocardiography Guided Cardiac Resynchronization Therapy Clinical Investigation
Ruschitzka et al., The New England Journal of Medicine 2013
- 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
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).
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
- 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
|Key Inclusion Criteria|
|Key Exclusion Criteria|
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