Phase
Condition
Heart Failure
Diabetes Prevention
Cardiac Disease
Treatment
N/AClinical Study ID
Ages > 21 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subjects greater than 21 years old.
Subjects with functional class (NYHA) III ischemic heart failure.
Subjects who have attempted "best" cardiac medical therapy including long-actingnitrates, maximal use of beta-adrenergic blocking agents, and angiotensin-convertingenzyme inhibitors without control of symptoms.
Subjects must be identified as non-candidates for conventional revascularization bytheir referring cardiologist. The patient's angiogram will then be reviewed by anindependent interventional cardiologist and independent cardiac surgeon to determineif the patient is eligible for revascularization.
Subjects must have left ventricular ejection fraction <40% by echocardiography.
All subjects must have a recent coronary angiogram (within the last 1 year) todocument the coronary anatomy and insure the presence of coronary disease that is notamenable to standard revascularization procedures.
Have serum B-type Natriuretic Peptide (BNP) level >100 pg/ml.
Exclusion
Exclusion Criteria:
Myocardial infarction (Q wave or non-Q wave defined as CKMB >3 times normal) within 30days of treatment.
Successful coronary revascularization procedures within 3 months of study enrollment.
Documented stroke or transient ischemic attack (TIA) within 60 days of studyenrollment.
NYHA Class I, II or IV heart failure and patients with idiopathic or non-ischemicheart failure.
History of severe aortic stenosis (aortic valve area < 1.0 cm2) or insufficiency (>2+); severe mitral stenosis (mitral valve area <1.5 cm2); or severe mitralinsufficiency(>2+).
Implantation of biventricular pacemaker within 90 days of study treatment.
Severe co-morbidity associated with a reduction in life expectancy of less than 1year, such as chronic medical illness (i.e. severe chronic obstructive pulmonarydisease, renal failure or cancer).
Study Design
Connect with a study center
Northwestern University
Chicago, Illinois 60611
United StatesSite Not Available

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