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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2006 by BioVentrix.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
BioVentrix
ClinicalTrials.gov Identifier:
NCT00326690
First received: May 15, 2006
Last updated: June 8, 2006
Last verified: May 2006

May 15, 2006
June 8, 2006
November 2005
Not Provided
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.
Same as current
Complete list of historical versions of study NCT00326690 on ClinicalTrials.gov Archive Site
Secondary objectives will examine the difference in heart failure symptoms between the two groups.
Same as current
Not Provided
Not Provided
 
Study Tests Whether a Standardized LVR Performed With the Blue Egg Device Improves Cardiopulmonary Exercise Capacity
A Prospective, Randomized Trial Using a reproduciBLe volUmE-Measurement stratEGy in the surGical Reconstruction of the Ischemic Cardiomyopathic Heart

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Congestive Heart Failure
  • Ischemic Cardiomyopathy
  • Coronary Artery Disease
  • Myocardial Diseases
Device: Blue Egg Device
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
July 2007
Not Provided

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
Both
18 Years and older
Yes
Contact: Dee L Bennett, RN, BSN 770-438-8874 dbennett@essentialgroupinc.com
Contact: Jim Rung 847-855-7662 jrung@essentialgroupinc.com
United States,   Germany
 
NCT00326690
BioVentrix - Blue Egg Trial™
Not Provided
Not Provided
BioVentrix
Not Provided
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
BioVentrix
May 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP