EchoCRT Trial Enrolls First Europeans to Investigate Resynchronization in Heart Failure Patients


December 4, 2008

December 4, 2008 - BIOTRONIK said this week the first European patients have been enrolled into the EchoCRT (Echocardiography guided Cardiac Resynchronization Therapy) trial by the team of physicians at Hospital Clinic in Barcelona, Spain.

The trial will be led by Professor Josep Brugada, M.D., director of the Thorax Institute, chairman of the cardiology department, EchoCRT Executive Committee member and president of the European Heart Rhythm Association. The EchoCRT trial is the largest prospective, randomized, double-blind, international, multicenter clinical trial of its kind. It is designed to demonstrate that optimal medical therapy plus CRT reduces all-cause mortality or first hospitalization for worsening heart failure in the study population compared to optimal medical therapy alone. Eligible patients must have echocardiographic evidence of left ventricular dyssynchrony (discoordinated pumping action of the heart) with a “narrow QRS” width (<130 ms). All patients in the study will receive current standard pharmacological therapy and all be implanted with the BIOTRONIK Lumax HF-T CRT-D device prior to randomization, either to the group receiving active CRT or the group receiving pharmacological therapy alone. Patients will be followed for a mean duration of 24 months. The study commenced in August 2008 with the enrollment of the first patient in the U.S.

Worldwide 125 sites will participate in EchoCRT and 80 of these sites are located in Europe and Australia. Overall, it is planned that 700 of the target 1,258 patients to be randomized to the study will be recruited from European sites in Austria, Belgium, Czech Republic, Denmark, France, Germany, Netherlands, Spain, Switzerland and the U.K.

Cardiac resynchronization therapy (CRT) is a proven, life-saving, device-based treatment for certain heart failure patients with ventricular dyssynchrony. Patients enrolled in the EchoCRT study are implanted with the Lumax HF-T CRT-D device. The maker said these new cardiac devices are equipped with pioneering features, such as BIOTRONIK Home Monitoring, providing the physician with automatic, remote updates on their patient’s cardiovascular and device status.

“EchoCRT will answer important questions about device-based treatment for hundreds of thousands of heart failure patients,” said Professor Frank Ruschitzka, M.D., University of Zürich, Executive Committee co-chairman and international co-principal investigator for EchoCRT. “We are looking forward to the results of EchoCRT to know whether the majority of heart failure patients can also benefit from device-based therapy.”

EchoCRT is an investigator clinical trial led by the University of Zürich. GE echocardiography equipment will be utilized throughout EchoCRT and GE, as a clinical cooperation partner to BIOTRONIK in this study, will provide training and technical support in order to reduce data variability and ensure optimal reliability of outcomes. BIOTRONIK is the sole sponsor of the EchoCRT study being conducted under an investigational device exemption (IDE) granted by the FDA.

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