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Study Tests Whether a Standardized LVR Performed With the Blue Egg Device Improves Cardiopulmonary Exercise Capacity
This study is currently recruiting participants.
Verified by BioVentrix, May 2006
First Received: May 15, 2006   Last Updated: June 8, 2006   History of Changes
Sponsored by: BioVentrix
Information provided by: BioVentrix
ClinicalTrials.gov Identifier: NCT00326690
  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 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

Resource links provided by NLM:


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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional 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 and Messenger J. Cardiac resynchronization in chronic heart failure. N Engl J Med 346: 1845-1853, 2002.
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. No abstract available.
Hjalmarson A, Goldstein S, Fagerberg B, Wedel H, Waagstein F, Kjekshus J, Wikstrand J, El Allaf D, Vitovec J, Aldershvile J, Halinen M, Dietz R, Neuhaus KL, Janosi 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. Long-term mechanical left ventricular assistance 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.

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

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

Study placed in the following topic categories:
Arterial Occlusive Diseases
Coronary Disease
Heart Failure
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Arteriosclerosis
Ischemia
Cardiomyopathies
Coronary Artery Disease

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

ClinicalTrials.gov processed this record on September 01, 2009