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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2006 by BioVentrix.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00326690
First Posted: May 17, 2006
Last Update Posted: June 9, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
BioVentrix
  Purpose
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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized Trial Using a reproduciBLe volUmE-Measurement stratEGy in the surGical Reconstruction of the Ischemic Cardiomyopathic Heart

Further study details as provided by BioVentrix:

Primary Outcome Measures:
  • A 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.

Secondary Outcome Measures:
  • Secondary objectives will examine the difference in heart failure symptoms between the two groups.

Estimated Enrollment: 100
Study Start Date: November 2005
Estimated Study Completion Date: July 2007
Detailed 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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Be 18 years of age or older
  • Have symptomatic heart failure consistent with NYHA Class III or IV
  • Have been treated, in the opinion of the Principal Investigator, for at least 12 weeks with an optimized pharmacological regimen, including no substantial dosage titration for the last 4 weeks. This will typically mean that the subject has had (unless intolerant) appropriate doses of angiotensin-converting enzyme (ACE) inhibitors, beta-blockers (β-blockers) and/or aldosterone inhibitors and diuretics.
  • Have a dilated left ventricular (LV) with an LV end-systolic volume index (LVESVI) of 60 ml/m² and an akinetic or dyskinetic anterior wall
  • Have an LV ejection fraction less than or equal to 35%
  • Have an MVO2 of equal to or greater than 10, but equal to or less than 16 ml O2/min/kg
  • Have demonstrated myocardial infarction without viability on a dobutamine stress echocardiogram in a region considered for surgery. Alternatively, have demonstrated the same physiological feature with gadolinium/magnetic resonance imaging (MRI) procedures or other sophisticated methodology for viability assessment.
  • Agree to be compliant with the study protocol and willing and able to return for follow-up

Exclusion Criteria:

  • Have had a myocardial infarction within 90 days of consent
  • Be inotrope or intra-aortic balloon pump (IABP) dependent
  • Require, in the judgment of the Principal Investigator, cardiac surgery that cannot be deferred for 6 months, such as subjects with:

    • left main coronary artery disease
    • intractable ventricular arrhythmias
    • Canadian Cardiovascular Society Angina Class III or IV symptoms
    • aortic stenosis or insufficiency requiring replacement
    • 3+ or 4+ mitral regurgitation
  • Have any comorbid medical condition that is a contraindication to cardiac surgery (e.g., renal failure, coagulopathy, severe chronic obstructive pulmonary disease [COPD], cerebrovascular accident [CVA], prior stroke, known malignancy etc.)
  • Have congestive heart failure (CHF) due to a cause other than ischemic cardiomyopathy
  • Have a history of radiation therapy to the chest or mediastinum
  • Have exercise tolerance limited by a condition other than heart failure
  • Be unable to perform cardiopulmonary stress test
  • Have a history of alcohol abuse, drug addiction, or other psychosocial condition that would preclude successful participation or realization of benefit from the trial in the opinion of the Principal Investigator.
  • Be a female of child-bearing age who is pregnant or does not agree to use standard methods of birth control.
  • Carry a diagnosis of an illness other than CHF with life expectancy less than 12 months.
  • Participating in another trial (other than non-therapeutic or interventional observation) within the last 30 days or less than 60 days after completion of a heart failure drug trial.
  • Biventricular pacemaker implantation and/or activation within the past 60 days
  • Percutaneous coronary intervention (PCI) with coronary revascularization within the last 60 days.
  • More than one prior sternotomy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00326690


Contacts
Contact: Dee L Bennett, RN, BSN 770-438-8874 dbennett@essentialgroupinc.com
Contact: Jim Rung 847-855-7662 jrung@essentialgroupinc.com

Locations
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         
Sponsors and Collaborators
BioVentrix
Investigators
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
  More Information

Publications:
Abraham WT, Fisher WG, Smith AL, Delurgio DB, Leon AR, Loh E, Kocovic DZ, Packer M, Clavell AL, Hayes DL, Ellestad M, Trupp RJ, Underwood J, Pickering F, Truex C, McAtee P, Messenger J; MIRACLE Study Group. Multicenter InSync Randomized Clinical Evaluation. Cardiac resynchronization in chronic heart failure. N Engl J Med. 2002 Jun 13;346(24):1845-53.
Athanasuleas CL, Stanley AW Jr, Buckberg GD, Dor V, DiDonato M, Blackstone EH. Surgical anterior ventricular endocardial restoration (SAVER) in the dilated remodeled ventricle after anterior myocardial infarction. RESTORE group. Reconstructive Endoventricular Surgery, returning Torsion Original Radius Elliptical Shape to the LV. J Am Coll Cardiol. 2001 Apr;37(5):1199-209.
Bristow MR, Saxon LA, Boehmer J, Krueger S, Kass DA, De Marco T, Carson P, DiCarlo L, DeMets D, White BG, DeVries DW, Feldman AM; Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure (COMPANION) Investigators. Cardiac-resynchronization therapy with or without an implantable defibrillator in advanced chronic heart failure. N Engl J Med. 2004 May 20;350(21):2140-50.
Cohn JN. The Vasodilator-Heart Failure Trials (V-HeFT). Mechanistic data from the VA Cooperative Studies. Introduction. Circulation. 1993 Jun;87(6 Suppl):VI1-4.
Hjalmarson A, Goldstein S, Fagerberg B, Wedel H, Waagstein F, Kjekshus J, Wikstrand J, El Allaf D, Vítovec J, Aldershvile J, Halinen M, Dietz R, Neuhaus KL, Jánosi A, Thorgeirsson G, Dunselman PH, Gullestad L, Kuch J, Herlitz J, Rickenbacher P, Ball S, Gottlieb S, Deedwania P. Effects of controlled-release metoprolol on total mortality, hospitalizations, and well-being in patients with heart failure: the Metoprolol CR/XL Randomized Intervention Trial in congestive heart failure (MERIT-HF). MERIT-HF Study Group. JAMA. 2000 Mar 8;283(10):1295-302.
Moss AJ, Zareba W, Hall WJ, Klein H, Wilber DJ, Cannom DS, Daubert JP, Higgins SL, Brown MW, Andrews ML; Multicenter Automatic Defibrillator Implantation Trial II Investigators. Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection fraction. N Engl J Med. 2002 Mar 21;346(12):877-83. Epub 2002 Mar 19.
Packer M, Bristow MR, Cohn JN, Colucci WS, Fowler MB, Gilbert EM, Shusterman NH. The effect of carvedilol on morbidity and mortality in patients with chronic heart failure. U.S. Carvedilol Heart Failure Study Group. N Engl J Med. 1996 May 23;334(21):1349-55.
Packer M, Coats AJ, Fowler MB, Katus HA, Krum H, Mohacsi P, Rouleau JL, Tendera M, Castaigne A, Roecker EB, Schultz MK, DeMets DL; Carvedilol Prospective Randomized Cumulative Survival Study Group. Effect of carvedilol on survival in severe chronic heart failure. N Engl J Med. 2001 May 31;344(22):1651-8.
Pitt B, Remme W, Zannad F, Neaton J, Martinez F, Roniker B, Bittman R, Hurley S, Kleiman J, Gatlin M; Eplerenone Post-Acute Myocardial Infarction Heart Failure Efficacy and Survival Study Investigators. Eplerenone, a selective aldosterone blocker, in patients with left ventricular dysfunction after myocardial infarction. N Engl J Med. 2003 Apr 3;348(14):1309-21. Epub 2003 Mar 31. Erratum in: N Engl J Med. 2003 May 29;348(22):2271.
Pitt B, Zannad F, Remme WJ, Cody R, Castaigne A, Perez A, Palensky J, Wittes J. The effect of spironolactone on morbidity and mortality in patients with severe heart failure. Randomized Aldactone Evaluation Study Investigators. N Engl J Med. 1999 Sep 2;341(10):709-17.
Rose EA, Gelijns AC, Moskowitz AJ, Heitjan DF, Stevenson LW, Dembitsky W, Long JW, Ascheim DD, Tierney AR, Levitan RG, Watson JT, Meier P, Ronan NS, Shapiro PA, Lazar RM, Miller LW, Gupta L, Frazier OH, Desvigne-Nickens P, Oz MC, Poirier VL; Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure (REMATCH) Study Group. Long-term use of a left ventricular assist device for end-stage heart failure. N Engl J Med. 2001 Nov 15;345(20):1435-43.
Starling RC, McCarthy PM, Buda T, Wong J, Goormastic M, Smedira NG, Thomas JD, Blackstone EH, Young JB. Results of partial left ventriculectomy for dilated cardiomyopathy: hemodynamic, clinical and echocardiographic observations. J Am Coll Cardiol. 2000 Dec;36(7):2098-103.
Young JB, Abraham WT, Smith AL, Leon AR, Lieberman R, Wilkoff B, Canby RC, Schroeder JS, Liem LB, Hall S, Wheelan K; Multicenter InSync ICD Randomized Clinical Evaluation (MIRACLE ICD) Trial Investigators. Combined cardiac resynchronization and implantable cardioversion defibrillation in advanced chronic heart failure: the MIRACLE ICD Trial. JAMA. 2003 May 28;289(20):2685-94.

ClinicalTrials.gov Identifier: NCT00326690     History of Changes
Other Study ID Numbers: BioVentrix - Blue Egg Trial™
First Submitted: May 15, 2006
First Posted: May 17, 2006
Last Update Posted: June 9, 2006
Last Verified: May 2006

Keywords provided by BioVentrix:
Congestive Heart Failure
Coronary Artery Disease
Ischemic Cardiomyopathy
Idiopathic Cardiomyopathy

Additional relevant MeSH terms:
Heart Failure
Ischemia
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases


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