Comparing the Safety and Efficacy of ASI-02 to Agitated Saline for Suspected Right-to-left Shunt

Inclusion Criteria:

1. Patient is clinically indicated for a saline contrast TTE study with a suspectedright-to-left shunt

2. Patient must be at least 18 years of age inclusive, at the time of signing theinformed consent

3. Able to communicate effectively with trial personnel

Exclusion Criteria:

1. Female patients who are pregnant or lactating. All women of child-bearing potential (WOCBP) must have a negative urine pregnancy test at screening regardless ofcontraceptive use history

2. WOCBP are excluded unless they have been using an adequate and medically approvedmethod of contraception to avoid pregnancy for at least 1 month prior to ASI-02 doseadministration

3. Allergy to polysorbate 80 (PS-80)

4. American Society of Anesthesiologists (ASA) physical status classification IV, V, orVI, except that participants with ASA physical status IV due solely to recentsuspected transient ischemic attack or cerebrovascular accident are eligible forinclusion

5. Current illness or pathology that in the opinion of the investigator would preventundergoing investigational product administration due to a significant safety riskto the patient

6. Uncontrolled arterial hypertension (defined as systolic blood pressure ≥ 200 mmHg ordiastolic blood pressure ≥ 110 mmHg) or arterial hypotension (defined as systolicblood pressure ≤ 90 mmHg)

7. Unstable cardiovascular status defined as:

8. myocardial infarction or unstable angina pectoris within 6 months prior toprocedure day

9. symptomatic valvular heart disease or moderate to severe stenotic valvularheart disease

10. clinically significant congenital heart defects (excluding an atrial septaldefect [ASD], patent foramen ovale [PFO], or pulmonary arteriovenousmalformation [PAVM])

11. current uncontrolled cardiac arrhythmias causing clinical symptoms requiringmedical intervention or hemodynamic compromise

12. acute pulmonary embolus or pulmonary infarction

13. acute myocarditis or pericarditis

14. acute aortic dissection

15. untreated atrial fibrillation

16. Any major surgery within 30 days prior to screening

17. Participation in any investigational drug, device, or placebo study within 30 daysprior to screening

18. Vulnerable adult participant populations (e.g., incarcerated or cognitivelychallenged adults)