Non-Ischemic Congestive Heart Failure
Non-ischemic congestive heart failure, also called non-ischemic cardiomyopathy, is heart failure that is unrelated to coronary artery disease and has nothing to do with a poor coronary artery blood supply. This type of heart failure means there is a weakness in the heart caused by something other than coronary artery disease. Angeles hospital offers stem cell application to treat Non-ischemic congestive heart failure and here is the inclusion and exclusion criteria for such treatment.
Eligible patients must meet ALL of the following inclusion criteria during the
screening/enrollment visit #1.
• Willing and able to sign informed consent
• Age >18 years and < 85 years • NYHA Class II-IV • Non-ischemic cardiomyopathy without an acute coronary syndrome during the prior 6 months • LVEF less than or equal to 35% measured by echocardiography at both local and investigative sites, AND: o Well-demarcated region of LV systolic dysfunction. o Left ventricular wall without mural thrombus and of thickness greater than 0.5 cm o No significant valvular disease including: Moderate-to-severe mitral regurgitation (3-4+), aortic stenosis (valve area <1.5 cm2), aortic insufficiency (3-4+)
At the time of the screening/enrollment visit #1, patients meeting ANY ONE of the
following criteria will be excluded from the study.
• Ischemic myocardial disease
• Limiting symptoms due to non-CHF causes, such as lung disease, peripheral vascular disease, arthritis or other musculoskeletal disorders
• Inability to complete a 6-minute walk test for any reason
• Need for intravenous CHF medications, chronic continuous oxygen therapy or oral steroids,
• CABG surgery within 150 days prior to screening
• Planned revascularization within 4 months following enrollment
• Aortic aneurysm or dilatation (>3.8 cm by echocardiography or other imaging modality)
• Peripheral vascular disease at or below the distal aorta that may interfere with MyoCath® use
• Hemodynamically significant pericardial disease
• Prior aortic or mitral valve replacement
• Biventricular pacing device implant within the last 3 months OR whose device is scheduled to be revised following enrollment in this trial
• Expected to receive or history of cardiac transplant, surgical remodeling procedure, left ventricular assist device
• Stroke or transient ischemic attack within 180 days of screening
• Positive pregnancy test in women of child bearing potential or who are unwilling to use an acceptable method of contraception.
• Drug or alcohol dependence
• Life expectancy of less than 1 year
• History of cancer (other than non-melanoma skin cancer or in situ cervical cancer) in the last five years
• Exposure to angiogenic therapy (including myocardial laser) or another investigational drug within 60 days of screening, or enrollment in any concurrent study that may confound the results of this study
• Any factors in the opinion of the Investigator which render the patient unsuitable for participation, that will interfere with conduct of the study or interpretation of the results.