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.
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Contacts:
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Amela Malja
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Director Marketing Communications
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BIOTRONIK GmbH & Co. KG.
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Woermannkehre 1
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12359 Berlin, Germany
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Tel + 49 (0) 30 68905 1400
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or
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Amy Klein
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Senior Project Manager, Clinical Studies
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BIOTRONIK, Inc.
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6024 Jean Road
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Lake Oswego, OR, USA 97035
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Tel + 1 800-547-0394 (toll free)
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www.biotronik.com
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