Last updated on June 2006

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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Coronary Artery Disease | Ischemic Cardiomyopathy | Myocardial Diseases | Congestive Heart Failure
  • Age: Between 18 - 100 Years
  • Gender: Male or Female
  • Other:
    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
    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

You may not be eligible for this study if the following are true:

  • 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
    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

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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