Healthcare Industry News:  electrotherapy 

Devices Cardiology FDA

 News Release - May 16, 2008

FDA Grants Approval to Begin Landmark Cardiac Resynchronization Therapy Study, EchoCRT

BERLIN & SAN FRANCISCO--(HSMN NewsFeed)--BIOTRONIK, the pioneer in wireless remote monitoring technologies for patients with implantable cardiac pacemakers and defibrillators, announced today the FDA approval to begin an international, prospective, randomized, controlled clinical trial to investigate the use of Cardiac Resynchronization Therapy (CRT) in heart failure (HF) patients with left ventricular systolic dysfunction.

The study, called Echocardiography guided Cardiac Resynchronization Therapy (EchoCRT), will include more than 1,250 patients with HF, already receiving current standard HF pharmacological therapy, with a narrow QRS width (< 130 ms) and echocardiographic evidence of left ventricular (LV) dyssynchrony. The study will involve 125 centers worldwide, and is being conducted according to FDA guidelines under an Investigational Device Exemption.

“The objective of this study 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 Frank Ruschitzka, M.D., University of Zurich, Executive Committee Co-Chairman and International Co-Principal Investigator of EchoCRT. Dr. Ruschitzka added, “EchoCRT will provide important scientific evidence for this large group of heart failure patients that currently lack treatment options beyond pharmacological therapy.”

“Previous randomized controlled trials with CRT had been limited to patients with a QRS width ≥ 120 - 130 ms who represent only 28% of all subjects with chronic heart failure,” said William T. Abraham, M.D., The Ohio State University, U.S. Principal Investigator of the study. “Results of recent small studies are encouraging that patients without electrical intraventricular conduction delays but with LV dyssynchrony assessed by echocardiography may benefit from CRT. Thus, withholding CRT treatment from a significant proportion of heart failure patients with a narrow QRS complex (< 120 ms) that have LV dyssynchrony could be unwise. EchoCRT aims to definitively address this question.”

Cardiovascular ultrasound equipment used to obtain echocardiograms will be limited to a single manufacturer, who will also provide training and technical support in order to reduce data variability and ensure optimal reliability of the outcomes. In addition, there will be a single Echo Core Lab which will independently confirm patient eligibility criteria.

Heart failure, with its associated morbidity and mortality, remains a major unresolved public health problem in the United States, Europe and throughout the world. It is estimated that HF affects nearly 5 million people in the United States, 6 million people in Europe and nearly 22 million people worldwide, and claims more than 300,000 lives annually in the United States alone. In many patients with HF, the clinical condition and outcome is worsened by poor coordination of the heart chambers in squeezing blood (known as ventricular dyssynchrony) leading to inefficient function of the heart as a pump. As a threshold seems to have been reached for drug therapy in HF, CRT with biventricular pacing has been proven to be effective in patients with severe HF and electrical intraventricular conduction delays (QRS ≥ 120-130 ms). Previous randomized clinical trials with CRT provide evidence of an improvement of symptoms, exercise capacity, quality-of-life, as well as significant reduction in all-cause mortality.

In recognition of its substantial clinical benefits, CRT has been recently included in the official guidelines for the management of HF patients. However, these guidelines have limited the recommendation to patients with a QRS width of ≥ 120 ms as a criterion for the prescription of CRT. Pending the outcomes of EchoCRT, the remaining 72% of HF patients with narrow QRS who are still in need could potentially be granted access to this promising therapy.

Johannes Holzmeister, M.D., University of Zurich, Executive Committee Co-Chairman and International Co-Principal Investigator of EchoCRT, reconfirmed, “It is established that CRT provides clinical benefit for heart failure patients with wide QRS. Now it is imperative that we understand the effects of CRT in patients with narrow QRS complex (< 130 ms) of whom up to 50% exhibit mechanical dyssynchrony.”

The EchoCRT study was designed by an independent executive committee comprised of internationally renowned cardiology experts from electrophysiology, cardiac imaging and heart failure, and a biostatistician to ensure the clinical validity of the study protocol. A Clinical Events Committee, Data Safety Monitoring Board and study statistician are all operationally independent of BIOTRONIK, the study sponsor. The University of Zurich Coordination and Data Center will scientifically support study operations and oversight in cooperation with BIOTRONIK. EchoCRT is registered on www.clinicaltrials.gov.

About BIOTRONIK GmbH & Co. KG

As one of the world’s 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 it 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.


Source: BIOTRONIK

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