Safety and Efficacy of SeeMore (TM) in Heart Patients

Inclusion Criteria:

• be at least 18 years of age.
• if female, be nonpregnant as evidenced by a serum pregnancy test and using a medically-approved method of birth control, or post-menopausal or surgically sterile
• provide written informed consent after having received oral and written information about the study
• be in stable health based on medical history, examination and tests
• have potassium, calcium and hematocrit values within normal limits
• have a prior known myocardial infarction

Exclusion Criteria:

• have a positive pregnancy test (females)
• received an investigational drug or device within 30 days prior to administration of SeeMore™
• have known hypersensitivity to ondansetron or other selective serotonin 5HT3 receptor blockers
• have a history of drug abuse or alcoholism
• have had a myocardial infarct, unstable angina, stroke of transient ischemic attack (TIA) within the past six months
• are taking a digitalis preparation or calcium channel blocker
• have arrhythmias requiring medication
• have a prolonged PR interval, history of an atrioventricular conduction disorder or sick sinus syndrome
• have a prolonged QTc interval, ventricular arrhythmia or history of torsades
• have NYHA Grade III or IV heart failure
• have abnormal liver function tests or a history of liver disease
• have uncontrolled hypertension
• have potassium, calcium or hematocrit values outside normal limits
• have altered a prescription medication within 14 days or an over-the-counter medication within 7 days
• are noncompliant or otherwise unlikely to perform as required by the protocol
• if a new cardiac arrhythmia develops prior to the scheduled time for SeeMore™ administration, SeeMore™ will be withheld.