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Multi-Center Study Demonstrates That Cambridge Heart's Microvolt T-Wave Alternans Identifies Patients at Risk of Ventricular Arrhythmias and Sudden Cardiac Death.


Business/Technology Editors & Health/Medical Writers

BEDFORD, Mass.--(BW HealthWire)--Nov. 28, 2000

New Research Published in the Journal of the American

College of Cardiology

Cambridge Heart, Inc. (NASDAQ NASDAQ
 in full National Association of Securities Dealers Automated Quotations

U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on
: CAMH) announced today that the results of a prospective multi-center clinical study have been reported in the current issue of the Journal of the American College of Cardiology The American College of Cardiology (ACC) is a nonprofit medical association established in 1949 to educate, research and influence health care public policy. The president for the 2006–2007 year is Steven E. Nissen. [1] The organization has 39 chapters in the U.S. . The company sponsored study found that patients with a positive Microvolt microvolt

one-millionth (10-6) of a volt; abbreviated µV.
 T-Wave Alternans test were 13.9 times more likely to have a serious ventricular arrhythmia or to die than patients with a negative Microvolt T-Wave Alternans test. Invasive electrophysiologic testing (EPS (Encapsulated PostScript) A PostScript file format used to transfer a graphic image between applications and platforms. EPS files contain PostScript code as well as an optional preview image in TIFF, WMF, PICT or EPSI, the latter being an ASCII-only format. ), the current gold standard for assessing arrhythmic ar·rhyth·mic
adj.
Lacking rhythm or regularity of rhythm.
 risk, was less predictive. Comparatively, patients with a positive versus negative EPS test were 4.7 times more likely to have a serious ventricular arrhythmia or to die.

This study involved 313 patients referred for EPS at nine major medical centers. An editorial accompanying the article stated that this is "the largest prospective study of patients scheduled to undergo electrophysiologic testing."

In this study the Microvolt T-Wave Alternans test was the only non-invasive independent predictor of risk of ventricular arrhythmias and death. EPS, an invasive diagnostic study, was the only other statistically significant independent predictor.

The authors of the study concluded that " T-Wave Alternans is a strong independent predictor of spontaneous ventricular arrhythmias or death."

The American Heart Association American Heart Association (AHA),
n.pr a national voluntary health agency that has the goal of increasing public and medical awareness of cardiovascular diseases and stroke, and thereby reducing the number of associated deaths and disabilities.
 statistics indicate that sudden cardiac death Sudden Cardiac Death Definition

Sudden cardiac death (SCD) is an unexpected death due to heart problems, which occurs within one hour from the start of any cardiac-related symptoms. SCD is sometimes called cardiac arrest.
 accounts for approximately one-half of all cardiac related deaths, or about 350,000 deaths in the United States each year.

"The publication of these study results, together with the recent publication in The Lancet of a study of congestive heart failure congestive heart failure, inability of the heart to expel sufficient blood to keep pace with the metabolic demands of the body. In the healthy individual the heart can tolerate large increases of workload for a considerable length of time.  patients, provides further scientific validation of the powerful predictive accuracy of our Microvolt T-Wave Alternans technology," stated Jeffrey Arnold, CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board.  and Chairman of Cambridge Heart, Inc.

David Chazanovitz, President and Chief Operating Officer Chief Operating Officer (COO)

The officer of a firm responsible for day-to-day management, usually the president or an executive vice-president.
 of Cambridge Heart, Inc., added, "We believe that the long awaited publication of these results in this highly regarded journal will add significant credibility to our marketing efforts aimed at increasing the clinical use of our Microvolt T-Wave Alternans technology to save lives by identifying patients at risk for sudden cardiac death."

About the Cambridge Heart Microvolt Alternans Test

The Cambridge Heart Microvolt T-Wave Alternans Test measures extremely subtle beat-to-beat fluctuations in a person's heartbeat called microvolt T-wave alternans. These tiny heartbeat variations - measured at one millionth of a volt - are detected using proprietary Alternans Sensors while the heart rate is elevated by exercise, use of pharmacological agents or pacing. Extensive clinical research has shown that patients with symptoms of or at risk for life threatening arrhythmias who test positive for T-wave alternans using Cambridge Heart technology are at significant risk for subsequent sudden cardiac events including sudden death. Cambridge Heart's Microvolt Alternans Test is the only noninvasive test cleared by FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
 to identify patients at risk for sudden cardiac death.

About Cambridge Heart, Inc.

Cambridge Heart is engaged in the research, development and commercialization of products for the non-invasive diagnosis of cardiac disease. Using innovative technologies, the Company is addressing such key problems in cardiac diagnosis as the identification of those at risk of sudden cardiac arrest, the early detection of coronary artery disease coronary artery disease, condition that results when the coronary arteries are narrowed or occluded, most commonly by atherosclerotic deposits of fibrous and fatty tissue. , and the prompt and accurate diagnosis of heart attack. The Company, started in 1992, is based in Bedford, Mass., and is traded on the NASDAQ/NMS under the symbol CAMH. Cambridge Heart can be found on the World Wide Web at www.cambridgeheart.com.

Statements made in this press release that are not historical facts include forward-looking statements that involve risks and uncertainties. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include uncertainties associated with regulatory approval processes, market acceptance and other factors that are included in Cambridge Heart's Annual Report on Form 10-K for the year ending December 31,1999.
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Publication:Business Wire
Geographic Code:1USA
Date:Nov 28, 2000
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