User Manual Part 2

CLINICAL STUD Y - MADIT II
C-9
• NYHA functiona l C la ss IV
• Current use of antiarrhythmic agents except when indicated for atrial
arrhythmias
• Coronary artery bypass graft surgery or PTCA within the past 3 months
• Enzyme-p ositive myocardial infarction ≤ 30 days prior to enrollment
• Patients with angiographic evidence of coronary disease who are
candidates for coronary revascularization and are likely to undergo
coronary artery bypass graft s urge ry or PTCA in the forese eab le future
• Patients with irreversible brain damage from preexisting cerebral disease
• Women of childbearing potential not using medically prescribed
contraceptive measures
• Presence of any disease, other than the patient’s cardiac disease,
associated with a reduced likelihood of survival for the duration of the trial,
e.g., cancer, uremia (BUN ≥ 70 mg% and/or creatinine ≥ 30 mg%)
• Patients participating in other clinical heart disease trials
• Patients unwilling o r u n ab le t o c oo perate with the study due to dementia,
psychological, or other related reasons
• Patients who were unable to participate due to one or more logistical
considerations
• Patient’s primary care physician refuses to allow patient to participate
• Patients who are on the heart transplant list. If the patient is pending
evaluation for the heart transplant list, the patient cannot be enrolled in
MADIT II until it is definitively determined that the patient will NOT be
placed on the transplant list
• ICD cannot be implanted due to anatomical abnormality or other medical
problem
- DRAFT -