Study Tests Whether a Standardized LVR Performed With the Blue Egg Device Improves Cardiopulmonary Exercise Capacity
Congestive Heart Failure, Ischemic Cardiomyopathy, Coronary Artery Disease
About this trial
This is an interventional treatment trial for Congestive Heart Failure focused on measuring Congestive Heart Failure, Coronary Artery Disease, Ischemic Cardiomyopathy, Idiopathic Cardiomyopathy
Eligibility 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
Sites / Locations
- Cedar Sinai Department of Cardiothoracic Surgery
- St. Joseph's Hospital
- University of Maryland College of Medicine
- University of Michigan
- NYU College of Medicine
- Drexel University College of Medicine
- University of Pennsylvania School of Medicine
- University of Virginia College of Medicine
- St. Joseph's Hospital
- Heart Center Leipzig
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
treatment
Control