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

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