EchoCRT Study Will Investigate Benefits Of Cardiac Resynchronization Therapy In Patients With Heart Failure

Main Category: Cardiovascular / Cardiology
Also Included In: Clinical Trials / Drug Trials;  Medical Devices / Diagnostics
Article Date: 29 Aug 2008 - 3:00 PDT

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BIOTRONIK announced the enrollment of the first patient into the EchoCRT (Echocardiography guided Cardiac Resynchronization Therapy) study. Drs William T. Abraham and Ralph Augostini at The Ohio State University Medical Center in Columbus, Ohio, USA, enrolled and implanted the Lumax HF-T CRT-D device in the first patients in EchoCRT. This technologically advanced cardiac device has many industry-leading features to save and enhance patients' lives and equipped with BIOTRONIK Home Monitoring® enables wireless, automatic daily data transmission of patients' cardiovascular and device status.

"The objective of EchoCRT is 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" said Dr Johannes Holzmeister, University of Zürich, Executive Committee Co-Chairman and International Co-Principal Investigator of EchoCRT. He added, "EchoCRT will provide valuable scientific evidence for this large group of heart failure patients who currently lack treatment options beyond pharmacological therapy."

"Cardiac resynchronization is a proven life-saving device-based treatment for certain heart failure patients with ventricular dyssynchrony, that is, discoordinated pumping action of the heart," Dr Abraham, Director of the Division of Cardiovascular Medicine at The Ohio State University Medical Center and US Principal Investigator of the study, explained. "Previous randomized controlled trials with CRT have been limited to patients with a so-called 'wide QRS,' an electrocardiogram (ECG) anomaly that shows longer-than-normal ventricular activity (QRS width ≥ 120 - 130 ms), who represent only 30% of all subjects with chronic heart failure. EchoCRT is designed to demonstrate whether patients with ventricular dyssynchrony but 'narrow QRS' or normal ventricular electrical activity on the ECG, may derive the same life-saving benefits from CRT device therapy as other heart failure patients."

As the largest, prospective, randomized, double-blind, international, multicenter clinical trial of its kind, the landmark EchoCRT study will randomize more than 1,250 patients with heart failure, already receiving current standard pharmacological therapy, with a 'narrow QRS' width (<130 ms) and echocardiographic evidence of left ventricular dyssynchrony. All patients will be implanted with the BIOTRONIK Lumax HF-T CRT-D device with BIOTRONIK Home Monitoring®. The Home Monitoring data will be used in a pre-specified analysis to evaluate the frequency and duration of irregular heart rhythms. Patients will be followed for a mean duration of 24 months. The trial is being conducted at approximately 125 investigational centers worldwide, including sites in Australia, Canada, Israel, Europe and the US.

In recognition of its substantial clinical benefits, CRT has been recommended in both the European Society of Cardiology (ESC) Guidelines and in the American College of Cardiology (ACC)/American Heart Association (AHA) Guidelines for the diagnosis and treatment of chronic heart failure. However, these guidelines have limited the application of CRT to patients with a QRS width of ≥ 120 ms.1, 2 EchoCRT will assess whether some of the remaining 70% of heart failure patients with 'narrow QRS' could benefit from CRT therapy.

"The clinical community has long been intrigued as to whether 'narrow-QRS' heart failure patients with ventricular dyssynchrony would benefit from CRT," stated Kevin Mitchell, BIOTRONIK Vice President Clinical Studies. "The EchoCRT 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. BIOTRONIK is proud to support this trial, which is part of our enduring commitment to landmark clinical research, to provide physicians with scientifically-sound evidence on which to base their clinical decisions. BIOTRONIK is also committed to improving patient outcomes and to achieve this, the company has significantly expanded its clinical trial program and has embarked on four large, international, landmark trials, including EchoCRT."

"Chronic heart failure is associated with a poor prognosis with considerably shortened survival and repeated hospitalizations. The vast majority of patients with heart failure present with a narrow QRS and do not currently receive CRT. The EchoCRT trial will test the hypothesis whether CRT improves outcomes in this large subset of heart failure patients," commented Dr Frank Ruschitzka, University of Zürich, Executive Committee Co-Chairman and International Co-Principal Investigator of EchoCRT.

EchoCRT is an investigator initiated large-scale, prospective, randomized, controlled clinical trial and will be led by the University of Zürich. GE echocardiography equipment will be utilized throughout the EchoCRT study 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.

Reference

1. Swedberg K et al. Guidelines for the diagnosis and treatment of chronic heart failure. Eur Heart J. 2005; 26:1115-1140.

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.

About BIOTRONIK GmbH & Co. KG

As one of the worlds leading cardiovascular medical device companies, with several million implanted devices, BIOTRONIK is present in all world markets. Known for having its finger on the pulse of the medical community, BIOTRONIK helps to assess the challenges physicians face, and provides the best solutions, be they cardiac implants, minimal invasive devices or other products and services ranging from diagnosis to electrotherapy and vascular intervention or therapy management. Quality, innovation, and reliability define BIOTRONIK and its growing success, and deliver confidence and peace of mind to physicians and their patients worldwide.

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