NCT06938347 · Agitated Solutions, Inc.
Comparing the Safety and Efficacy of ASI-02 to Agitated Saline for Suspected Right-to-left Shunt
(ENHANCE)
What this study is about
This is a phase 3, conducted at multiple hospitals, where both patients and doctors know the treatment given, blinded, crossover trial in which each participant will undergo a randomly assigned sequence of ASI-02 and agitated saline the usual treatment (SoC) via a saline contrast transthoracic echocardiogram (TTE) study.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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)
Where
- Chicago, Illinois
- Rochester, Minnesota
- Saint Cloud, Minnesota
- Jackson, Mississippi
- New York, New York
- Milwaukee, Wisconsin
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 6, 2026 · Source of record for eligibility and locations