Last updated on June 2006

Study Tests Whether a Standardized LVR Performed With the Blue Egg Device Improves Cardiopulmonary Exercise Capacity

Brief description of study

The purpose of the present prospective, randomized study is to investigate the clinical effectiveness of standardized left ventricular reconstruction surgery (LVR). In order to standardize the procedure, the operation will be performed with the Blue Egg, manufactured by BioVentrix, a subsidiary of CHF Technologies, Inc.

Detailed Study Description

The primary objective of this study is to test whether a standardized Left Ventricular Reconstruction (LVR) performed with the Blue Egg device improves cardiopulmonary exercise capacity in subjects with stable New York Heart Association (NYHA) Class III or IV heart failure due to ischemic cardiomyopathy with an akinetic or dyskinetic anterior wall. This shall be accomplished by comparing changes in cardiopulmonary exercise between a group of subjects treated with LVR and optimal medical therapy (Treatment) to a group treated with optimal medical therapy alone (Control). Secondary objectives will examine the difference in heart failure symptoms between the two groups. The primary hypothesis is that the average change in peak oxygen consumption (MVO2) observed in the treatment group from baseline to 6 months post surgery date is at least 1.2 ml O2/min/kg greater than the average change observed in the control group in the same time frame.

Clinical Study Identifier: NCT00326690

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Eli Gang, MD

Cedar Sinai Department of Cardiothoracic Surgery
Los Angeles, CA United States
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Robert Lazzara, MD

St. Joseph's Hospital
St. Petersburg, FL United States
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Omar Lattouf, MD

Emory University
Atlanta, GA United States
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Frances Johnson, MD

University of Maryland College of Medicine
Baltimore, MD United States
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Adam Saltman, MD

University of Massachusetts
Worcester, MA United States
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David Dyke, MD

University of Michigan
Ann Arbor, MI United States
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Ulrich Jorde, MD

NYU College of Medicine
New York, NY United States
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Howard J. Eisen, MD

Drexel University College of Medicine
Philadelphia, PA United States
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Mariell Jessup, MD

University of Pennsylvania School of Medicine
Philadelphia, PA United States
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James D. Bergin, MD

University of Virginia College of Medicine
Charlottesville, VA United States
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Jan Gummert, MD

Heart Center Leipzig
Leipzig, Germany
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Recruitment Status: Open

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