Landmark EchoCRT trial enrolls first European patients
BIOTRONIK announced that the first European patients have been enrolled into the EchoCRT (Echocardiography guided Cardiac Resynchronization Therapy) trial by the team of physicians at Hospital Clínic in Barcelona, Spain, led by Professor Dr. Josep Brugada, Director of the Thorax Institute, Chairman of the Cardiology Department, EchoCRT Executive Committee Member and President of the European Heart Rhythm Association.
The landmark 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 US.
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 UK.
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. These state-of-the-art 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.
"We already know that CRT is a life-saving treatment for heart failure patients with ventricular dyssynchrony and 'wide QRS'*," explained Professor Dr. Josep Brugada.
"Indeed, guidelines from the European Society of Cardiology (ESC) and from the American College of Cardiology (ACC)/American Heart Association (AHA) already recommend CRT for patients with a QRS width of ?120 ms.1,2 This however only helps 30% of patients with chronic heart failure." Dr. Lluis Mont Girbau, Arrhythmia Unit Director, Hospital Clínic, Barcelona, Spain, who carried out the first European implant in the EchoCRT trial, added, "EchoCRT is designed to show whether the remaining 70% of patients with ventricular dyssynchrony and 'narrow QRS' (normal ventricular electrical activity) can also benefit from CRT therapy."
Dr. Johannes Holzmeister, University of Zürich, Executive Committee Co-Chairman and International Co-Principal Investigator of EchoCRT commented, "These patients experience high levels of morbidity, hospitalization and mortality and there is a significant need for new treatments beyond current pharmacological therapies to help improve both the quality and duration of their lives.
"EchoCRT will answer important questions about device-based treatment for hundreds of thousands of heart failure patients," remarked Professor Dr. Frank Ruschitzka, 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."
* An electrocardiogram (ECG) anomaly that shows longer-than-normal ventricular activity (QRS width ?120-130 ms)
1. Dickstein K et al. ESC guidelines for the diagnosis and treatment of acute and chronic heart failure 2008. Eur Heart J 2008; 29:2388-2442.
2. Hunt SA et al. ACC/AHA 2005 guideline update for the diagnosis and management of chronic heart failure in the adult - summary article. J Am Coll Cardiol 2005; 46:1116-1143.
EchoCRT is an investigator clinical trial led by the University of Zürich. The study has been designed under guidance from an executive steering committee of 11 internationally-renowned academic specialists in electrophysiology, heart failure and echocardiography who carefully considered earlier studies in developing the EchoCRT design. 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.
As one of the world's leading cardiovascular medical device companies, with several million implanted devices, BIOTRONIK is represented in over 100 countries with its global workforce of more than 4000 employees. Known for having its finger on the pulse of the medical community, BIOTRONIK assesses the challenges physicians face, and provides the best solutions for all phases of patient care, ranging from diagnosis to treatment to patient management. Quality, innovation and reliability define BIOTRONIK and its growing success, and deliver confidence and peace of mind to physicians and their patients worldwide.