Status:
RECRUITING
Comparing the Safety and Efficacy of ASI-02 to Agitated Saline for Suspected Right-to-left Shunt
Lead Sponsor:
Agitated Solutions, Inc.
Collaborating Sponsors:
Bright Research Partners
Conditions:
Right-To-Left Shunt
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 cont...
Detailed Description
The primary objective is to determine the safety of ASI-02 and its agreement with agitated saline SoC for detection of right-to-left shunt in saline contrast studies utilizing TTE in the intended sett...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Female patients 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
- WOCBP are excluded unless they have been using an adequate and medically approved method of contraception to avoid pregnancy for at least 1 month prior to ASI-02 dose administration
- Allergy to polysorbate 80 (PS-80)
- American Society of Anesthesiologists (ASA) physical status classification IV, V, or VI, except that participants with ASA physical status IV due solely to recent suspected transient ischemic attack or cerebrovascular accident are eligible for inclusion
- Current illness or pathology that in the opinion of the investigator would prevent undergoing investigational product administration due to a significant safety risk to the patient
- 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)
- Unstable cardiovascular status defined as:
- myocardial infarction or unstable angina pectoris within 6 months prior to procedure day
- symptomatic valvular heart disease or moderate to severe stenotic valvular heart disease
- clinically significant congenital heart defects (excluding an atrial septal defect \[ASD\], patent foramen ovale \[PFO\], or pulmonary arteriovenous malformation \[PAVM\])
- current uncontrolled cardiac arrhythmias causing clinical symptoms requiring medical intervention or hemodynamic compromise
- acute pulmonary embolus or pulmonary infarction
- acute myocarditis or pericarditis
- acute aortic dissection
- untreated atrial fibrillation
- Any 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 participant populations (e.g., incarcerated or cognitively challenged adults)
Key Trial Info
Start Date :
November 5 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06938347
Start Date
November 5 2025
End Date
June 1 2026
Last Update
December 3 2025
Active Locations (5)
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1
Northwestern University
Chicago, Illinois, United States, 60611
2
Mayo Clinic
Rochester, Minnesota, United States, 55905
3
Jackson Heart Clinic
Jackson, Mississippi, United States, 39216
4
NYU Langone Health
New York, New York, United States, 10016