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

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.

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