DEF-315 Better Accuracy in Ejection Fraction (EF) Assessment With DEFINITY
Condition: Cardiac Disease
MeSH terms: Heart Diseases
Intervention: DEFINITY®
Intervention description: All subjects will receive a single dose of DEFINITY®
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 160.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Left Ventricular Ejection Fraction; DEFINITY®; Enhanced Echocardiogram; Cardiac Magnetic Resonance

Summary:

      This is a Phase 3, prospective, open-label, multicenter study to evaluate Left Ventricular
      Ejection Fraction (LVEF) measurement accuracy and reproducibility of DEFINITY®
      contrast-enhanced and unenhanced echocardiography as compared with non-contrast cardiac
      magnetic resonance imaging (CMR) used as the truth standard.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Men and women ≥ 18 years of age in sinus rhythm

          2. Able to communicate effectively with trial personnel

          3. LVEF measurements obtained via 2D Echo with or without contrast obtained within 6
             months prior to enrollment (Day 0)

          4. Has provided signed informed consent after receiving a verbal and written explanation
             of this clinical trial

        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).