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Sponsored by: |
BioVentrix |
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Information provided by: | BioVentrix |
ClinicalTrials.gov Identifier: | NCT00326690 |
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.
Condition | Intervention | Phase |
---|---|---|
Congestive Heart Failure Ischemic Cardiomyopathy Coronary Artery Disease Myocardial Diseases |
Device: Blue Egg Device |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Prospective, Randomized Trial Using a reproduciBLe volUmE-Measurement stratEGy in the surGical Reconstruction of the Ischemic Cardiomyopathic Heart |
Estimated Enrollment: | 100 |
Study Start Date: | November 2005 |
Estimated Study Completion Date: | July 2007 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Require, in the judgment of the Principal Investigator, cardiac surgery that cannot be deferred for 6 months, such as subjects with:
Contact: Dee L Bennett, RN, BSN | 770-438-8874 | dbennett@essentialgroupinc.com |
Contact: Jim Rung | 847-855-7662 | jrung@essentialgroupinc.com |
United States, California | |
Cedar Sinai Department of Cardiothoracic Surgery | Not yet recruiting |
Los Angeles, California, United States, 90048 | |
Contact: Tracy Gerez tracey.gerez@cvmg.com | |
Principal Investigator: Eli Gang, MD | |
United States, Florida | |
St. Joseph's Hospital | Not yet recruiting |
St. Petersburg, Florida, United States, 33709 | |
Contact: Tina Merola 727-280-6602 merolat@heartsurgery-csa.com | |
Principal Investigator: Robert Lazzara, MD | |
United States, Georgia | |
Emory University | Not yet recruiting |
Atlanta, Georgia, United States, 30322 | |
Contact: Shannon Smith 404-686-3373 shannon.smith@emoryhealthcare.org | |
Principal Investigator: Omar Lattouf, MD | |
United States, Maryland | |
University of Maryland College of Medicine | Not yet recruiting |
Baltimore, Maryland, United States, 21201 | |
Contact: Joanne Marshall 410-328-8790 jmarshal@medicine.umaryland.edu | |
Principal Investigator: Frances Johnson, MD | |
United States, Massachusetts | |
University of Massachusetts | Not yet recruiting |
Worcester, Massachusetts, United States, 01655 | |
Contact: Dawn Bombard 508-334-7027 bobardd@ummhc.org | |
Principal Investigator: Adam Saltman, MD | |
United States, Michigan | |
University of Michigan | Not yet recruiting |
Ann Arbor, Michigan, United States, 48109 | |
Contact: Pam Obriot 734-615-6170 pobriot@umich.edu | |
Principal Investigator: David Dyke, MD | |
United States, New York | |
NYU College of Medicine | Recruiting |
New York, New York, United States, 10016 | |
Contact: Karen Hager 212-263-4128 karen.hager@med.nyu.edu | |
Principal Investigator: Ulrich Jorde, MD | |
United States, Pennsylvania | |
Drexel University College of Medicine | Not yet recruiting |
Philadelphia, Pennsylvania, United States, 19102 | |
Contact: Colleen Poisker 215-762-8512 cpoisker@drexelmed.edu | |
Principal Investigator: Howard J. Eisen, MD | |
University of Pennsylvania School of Medicine | Not yet recruiting |
Philadelphia, Pennsylvania, United States, 19104 | |
Contact: Kimberly Craig 215-662-6900 ext 215-349-5603 craigk@uphs.upenn.edu | |
Principal Investigator: Mariell Jessup, MD | |
United States, Virginia | |
University of Virginia College of Medicine | Not yet recruiting |
Charlottesville, Virginia, United States, 22908 | |
Contact: Christine M. McDaniel, RN 434-924-0421 cmm5b@virginia.edu | |
Principal Investigator: James D. Bergin, MD | |
Germany | |
Heart Center Leipzig | Not yet recruiting |
Leipzig, Germany, 39 04289 | |
Contact: Simone Blaser 49(0341)8651422 blaeser@medizin.uni-leipzig.de | |
Principal Investigator: Jan Gummert, MD |
Principal Investigator: | Robert R. Lazzara, MD | St. Joseph's Hospital |
Principal Investigator: | Ulrich Jorde, MD | New York College of Medicine |
Principal Investigator: | David Dyke, MD | University of Michigan |
Principal Investigator: | James D. Bergin, MD | University of Virginia College of Medicine |
Principal Investigator: | Howard J Eisen, MD | Drexel University College of Medicine |
Principal Investigator: | Eli Gang, MD | Cedar Sinai Department of Cardiothoracic Surgery |
Principal Investigator: | Jan F Gummert, MD | Heart Center Leipzig |
Principal Investigator: | Mariell Jessup, MD | University of Pennsylvania |
Principal Investigator: | Frances L Johnson, MD | University of Maryland College of Medicine |
Principal Investigator: | Omar M. Lattouf, MD | Emory University |
Study ID Numbers: | BioVentrix - Blue Egg Trial™ |
Study First Received: | May 15, 2006 |
Last Updated: | June 8, 2006 |
ClinicalTrials.gov Identifier: | NCT00326690 History of Changes |
Health Authority: | United States: Institutional Review Board; Germany: Federal Institute for Drugs and Medical Devices |
Congestive Heart Failure Coronary Artery Disease Ischemic Cardiomyopathy Idiopathic Cardiomyopathy |
Arterial Occlusive Diseases Coronary Disease Heart Failure Heart Diseases Myocardial Ischemia |
Vascular Diseases Arteriosclerosis Ischemia Cardiomyopathies Coronary Artery Disease |
Arterial Occlusive Diseases Coronary Disease Heart Failure Pathologic Processes Heart Diseases Myocardial Ischemia |
Vascular Diseases Cardiovascular Diseases Arteriosclerosis Ischemia Cardiomyopathies Coronary Artery Disease |