DEF-315 Better Accuracy in Ejection Fraction (EF) Assessment With DEFINITY

Exclusion Criteria

• •1. Female subjects who are pregnant or lactating. All women of child bearing potential \[WOCBP\] must have a negative urine pregnancy test at screening regardless of contraceptive use history.
• •2. Women of child-bearing potential are excluded unless they:
• •1. are post-menopausal defined as amenorrhea ≥ 12 consecutive months, OR
• •2. have undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy), OR
• •3. have been using an adequate and medically approved method of contraception to avoid pregnancy for at least 1 month prior to DEFINITY® dose administration and be willing to continue using the same method for the duration of the study.
• •3. Current illness or pathology that would prevent undergoing investigational product administration due to a significant safety risk to the patient.
• •4. Uncontrolled arterial hypertension (defined as systolic blood pressure ≥ 200 mmHg or diastolic blood pressure ≥ 110 mmHg) or arterial hypotension (defined as systolic blood pressure ≤ 90 mmHg).
• •5. Unstable cardiovascular status defined as:
• •1. myocardial infarction or unstable angina pectoris within 6 months prior to enrollment/DEFINITY® dose administration day
• •2. transient ischemic attack or stroke within 3 months prior to DEFINITY® dose administration
• •3. symptomatic valvular heart disease or moderate to severe stenotic valvular heart disease
• •4. clinically significant congenital heart defects
• •5. current uncontrolled cardiac arrhythmias causing symptoms or hemodynamic compromise
• •6. acute pulmonary embolus or pulmonary infarction
• •7. acute myocarditis or pericarditis
• •8. acute aortic dissection
• •9. atrial fibrillation
• •6. any major surgery within 4 weeks prior to screening
• •7. known contraindications to undergoing CMR (e.g. implanted pacemakers, cardioverter, defibrillators) or claustrophobia
• •8. participation in any investigational drug, device, or placebo study within 30 days prior to screening
• •9. known hypersensitivity to perflutren, or any of the excipients in DEFINITY®
• •10. prisoners or those who are subject to compulsory detention or involuntary incarceration for treatment of either a psychiatric or physical illness (e.g., infectious disease).