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news.Biotronik, a cardiovascular medical device company, has announced that the first European patients have been enrolled into the echocardiography guided cardiac resynchronization therapy trial by the team of physicians at Hospital Clinic in Barcelona, Spain.
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The echocardiography guided cardiac resynchronization therapy (EchoCRT) trial is said to be the largest prospective, randomized, double-blind, international, multicenter clinical trial of its kind. It is designed to demonstrate that optimal medical therapy plus cardiac resynchronization therapy (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. 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, the Czech Republic, Denmark, France, Germany, Netherlands, Spain, Switzerland and the UK. Patients enrolled in the EchoCRT study are implanted with the Lumax HF-T CRT-D device. These cardiac devices are equipped with features such as Biotronik Home Monitoring, providing the physician with automatic, remote updates on their patient's cardiovascular and device status. Frank Ruschitzka, University of Zurich, executive committee co-chairman and international co-principal investigator for EchoCRT, said: "EchoCRT will answer important questions about device-based treatment for hundreds of thousands of heart failure patients. 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."