BIOTRONIK: EchoCRT clinical trial design validated with recent publication in European Heart Journal

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BIOTRONIK a manufacturer of implantable cardiac devices and sponsor of clinical research to advance patient care and evidence-based medicine announced the publication in the September 23, 2010 issue of the European Heart Journal of a peer-reviewed article that describes the rationale for the echocardiographic methods and dyssynchrony cutoff values selected for the EchoCRT study.

EchoCRT is a prospective, randomised, double-blind, investigator-initiated trial, sponsored by BIOTRONIK, that aims to evaluate the impact of cardiac resynchronisation therapy (CRT) in patients with advanced heart failure (NYHA Class III), narrow QRS complex, and documented mechanical dyssynchrony as assessed by echocardiography.

The article, “Association of intraventricular mechanical dyssynchrony with response to cardiac resynchronisation therapy in heart failure patients with a narrow QRS complex”, states that “EchoCRT will provide the answer for the effectiveness of CRT in patients with a narrow QRS complex and echocardiographic evidence of mechanical dyssynchrony. Until the final results of EchoCRT, a clinical value and potential benefit of CRT in heart failure patients with a narrow QRS complex and mechanical dyssynchrony remain unclear.”

“Because the current treatment guidelines apply only to patients classified as NYHA III or IV with a wide QRS complex, only about 30% of the total advanced heart failure population are eligible for CRT,” stated Dr. William T. Abraham, principal investigator of EchoCRT, and prof. of medicine and director of the division of cardiovascular medicine at Ohio state University. “Patients with a narrow QRS complex have no options besides pharmacological therapy. A positive answer to the hypothesis being investigated in EchoCRT has the potential to expand the indication for CRT to more than half of this narrow QRS population – that is to hundreds of thousands or even millions of patients in need.”

The EchoCRT trial will include 125 international sites and is being conducted according to FDA guidelines under an Investigational Device Exemption. Currently, more than 100 investigational centres are participating in the trial, with more than 500 subjects now enrolled worldwide. Approximately 40 percent of all centres are located in the US.

EchoCRT is led by Co-principal Investigators Dr Frank Ruschitzka and Dr Johannes Holzmeister, both of whom are based at the University of Zurich. EchoCRT will enrol more than 1,000 patients, who will be randomised to CRT or no CRT. Patients in both study arms will receive an implantable cardioverter-defibrillator (ICD) backup to protect against sudden cardiac death. The primary objective of the study is to determine whether CRT will reduce the combined endpoint of all-cause mortality or hospitalisation for cardiovascular events.

“At BIOTRONIK, we believe that clinical excellence is achieved by conducting studies of major significance where outcomes will provide answers to the most important clinical questions regarding the unmet needs of patients and physicians,” commented Marlou Janssen, global vice president of marketing & sales at BIOTRONIK.