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

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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