NCT06938347 Comparing the Safety and Efficacy of ASI-02 to Agitated Saline for Suspected Right-to-left Shunt
| NCT ID | NCT06938347 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Agitated Solutions, Inc. |
| Condition | Right-To-Left Shunt |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2025-11-05 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 300 participants in total. It began in 2025-11-05 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 contrast transthoracic echocardiogram (TTE) study.
Eligibility Criteria
Inclusion Criteria: 1. Patient is clinically indicated for a saline contrast TTE study with a suspected right-to-left shunt 2. Patient must be at least 18 years of age inclusive, at the time of signing the informed 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 of contraceptive use history 2. 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 3. Allergy to polysorbate 80 (PS-80) 4. 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 5. 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 6. 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) 7. Unstable cardiovascular status defined as: 1. myocardial infarction or unstable angina pectoris within 6 months prior to procedure day 2. symptomatic valvular heart disease or moderate to severe stenotic valvular heart disease 3. clinically significant congenital heart defects (excluding an atrial septal defect \[ASD\], patent foramen ovale \[PFO\], or pulmonary arteriovenous malformation \[PAVM\]) 4. current uncontrolled cardiac arrhythmias causing clinical symptoms requiring medical intervention or hemodynamic compromise 5. acute pulmonary embolus or pulmonary infarction 6. acute myocarditis or pericarditis 7. acute aortic dissection 8. untreated atrial fibrillation 8. Any major surgery within 30 days prior to screening 9. Participation in any investigational drug, device, or placebo study within 30 days prior to screening 10. Vulnerable adult participant populations (e.g., incarcerated or cognitively challenged adults)
Contact & Investigator
Akhil Narang, MD
PRINCIPAL INVESTIGATOR
Northwestern Medicine
Frequently Asked Questions
Who can join the NCT06938347 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Right-To-Left Shunt. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06938347 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 300 participants.
Is NCT06938347 currently recruiting?
Yes, NCT06938347 is actively recruiting participants. Contact the research team at pamela@agitatedsolutions.com for enrollment information.
Where is the NCT06938347 trial being conducted?
This trial is being conducted at Chicago, United States, Chicago, United States, Rochester, United States, Saint Cloud, United States and 4 additional locations.
Who is sponsoring the NCT06938347 clinical trial?
NCT06938347 is sponsored by Agitated Solutions, Inc.. The principal investigator is Akhil Narang, MD at Northwestern Medicine. The trial plans to enroll 300 participants.