Actively Recruiting
Comparing the Safety and Efficacy of ASI-02 to Agitated Saline for Suspected Right-to-left Shunt
Led by Agitated Solutions, Inc. · Updated on 2025-12-03
300
Participants Needed
5
Research Sites
29 weeks
Total Duration
On this page
Sponsors
A
Agitated Solutions, Inc.
Lead Sponsor
B
Bright Research Partners
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a phase 3, multicenter, open-label, blinded, crossover trial in which each participant will undergo a randomized sequence of ASI-02 and agitated saline standard of care (SoC) via a saline contrast transthoracic echocardiogram (TTE) study.
CONDITIONS
Official Title
Comparing the Safety and Efficacy of ASI-02 to Agitated Saline for Suspected Right-to-left Shunt
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient is clinically indicated for a saline contrast TTE study with a suspected right-to-left shunt
- Patient must be at least 18 years of age inclusive, at the time of signing the informed consent
- Able to communicate effectively with trial personnel
You will not qualify if you...
- Female patients who are pregnant or lactating
- Women of child-bearing potential must have a negative urine pregnancy test at screening
- Women of child-bearing potential must use medically approved contraception for at least 1 month before ASI-02 administration
- Allergy to polysorbate 80 (PS-80)
- American Society of Anesthesiologists physical status classification IV, V, or VI, except status IV related solely to recent suspected transient ischemic attack or cerebrovascular accident
- Current illness or condition posing significant safety risk for investigational product administration
- Uncontrolled arterial hypertension (systolic 60 200 mmHg or diastolic 60 110 mmHg) or arterial hypotension (systolic 40 mmHg)
- Unstable cardiovascular status including recent myocardial infarction or unstable angina within 6 months, symptomatic or moderate to severe valvular heart disease, significant congenital heart defects (excluding ASD, PFO, or PAVM), uncontrolled cardiac arrhythmias with symptoms, acute pulmonary embolus or infarction, myocarditis or pericarditis, aortic dissection, or untreated atrial fibrillation
- Major surgery within 30 days prior to screening
- Participation in any investigational drug, device, or placebo study within 30 days prior to screening
- Vulnerable adult populations such as incarcerated or cognitively challenged adults
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
2
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
3
Jackson Heart Clinic
Jackson, Mississippi, United States, 39216
Actively Recruiting
4
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
5
Toronto General
Toronto, Canada, M5G 2C4
Actively Recruiting
Research Team
P
Pamela Wolfe
CONTACT
R
Rebecca Zickert
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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