Congestive Heart Failure
Congestive heart failure is a condition in which the heart can not pump enough blood to the rest of the body. It is a long-term, chronic illness that tends to affect both sides of the heart, although it can affect the right or left side only. Angeles hospital uses stem cell application to treat congestive heart failure. Here is the inclusion and exclusion criteria for this 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 < 80 years • NYHA Class II-IV • 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.
• Non-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.