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Compares treatment options for Right-To-Left Shunt
Official title Comparing the Safety and Efficacy of ASI-02 to Agitated Saline for Suspected Right-to-left Shunt
ClinicalTrials.gov ID: NCT06938347
What this study is testing
What is Agitated Saline SoC?
Agitated Saline SoC is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for right-to-left shunt.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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 likely can't join if
- Female patients who are pregnant or lactating. All women of child-bearing potential (WOCBP) must have a negative urine pregnancy test at screening...
- WOCBP are excluded unless they have been using an adequate and medically approved method of contraception to avoid pregnancy for at least 1 month...
- 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...
- Current illness or pathology that in the opinion of the investigator would prevent undergoing investigational product administration due to a...
- Uncontrolled arterial hypertension (defined as systolic blood pressure ≥ 200 mmHg or diastolic blood pressure ≥ 110 mmHg) or arterial hypotension...
See the full eligibility 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
- 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...
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
- Rochester, Minnesota, United States
- Saint Cloud, Minnesota, United States
- Jackson, Mississippi, United States
- New York, New York, United States
- Milwaukee, Wisconsin, United States
- Toronto, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States; Rochester, Minnesota, United States; Saint Cloud, Minnesota, United States; Jackson, Mississippi, United States; New York, New York, United States; Milwaukee, Wisconsin, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.