Right-To-Left ShuntPhase 3ENHANCENCT06938347
Comparing the Safety and Efficacy of ASI-02 to Agitated Saline for Suspected Right-to-left Shunt
A Phase 3 study testing Agitated Saline SoC and ASI-02 in people with Right-To-Left Shunt, run by Agitated Solutions, Inc. at 8 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Right-To-Left Shunt
- What is being tested?
- Agitated Saline SoC and ASI-02
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 5 Nov 2025to Nov 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 18Show fewer
- 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)
Trial locations and contacts
8 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
8 sites in 2 countries
United States7 sites, 7 recruiting
- Recruiting
Northwestern University
Chicago, Illinois, 60611
Akhil Narang, MD
- Recruiting
AH Illinois Masonic Center
Chicago, Illinois, 60657
Sorin Danciu, MD
- Recruiting
Jackson Heart Clinic
Jackson, Mississippi, 39216
William Crowder, MD
- Recruiting
Aurora St. Lukes Medical Center
Milwaukee, Wisconsin, 53215
Renuka Jain, MD
- Recruiting
NYU Langone Health
New York, New York, 10016
Daniel Bamira, MD
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Sunil Mankad, MD
- Recruiting
CentraCare
Saint Cloud, Minnesota, 56303
Timothy Schuchard, MD
Canada1 site, 1 recruiting
- Recruiting
Toronto General
Toronto, M5G 2C4
Wendy Tsang, MD
About this study
Official title: A Phase 3, Open-label, Multicenter, Randomized Crossover Trial Comparing the Safety and Efficacy of ASI-02 to Agitated Saline for Suspected Right-to-left Shunt
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.
Read the 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 setting of use (opacifying the right heart). The investigation will be conducted in up to 8 investigational sites in the U.S. and Canada. Participants will receive n=2 ASI-02, n=4 agitated saline SoC injections as part of a single-day imaging session, with the overall duration for study participation of 24 to 48 hours.
- Conditions
- Right-To-Left Shunt
- Being tested
- Agitated Saline SoC, ASI-02
- Keywords
- Saline Contrast, Saline Contrast Transthoracic Echocardiogram, Transthoracic Echocardiogram, Agitated Saline Standard of Care, Echocardiogram, Transpulmonary Shunt
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Agitated Saline SoCDrug
The recommended initial dose of agitated saline SoC is approximately 10 mL of saline containing approximately 1 mL of air, per institutional policy, rapidly mixed (approximately 10-20 presses) to manufacture microbubbles. No additives are allowed to the saline, including blood, dextrose, or bacteriostatic saline.
ASI-02Drug
Each injection shall utilize one (1) ASI-02 product connected to one (1) pre-filled 10 mL 0.9% sodium chloride (saline) syringe. The ASI-02 investigational product will be connected to a standard luer lock connector and administered in its entirety. The intravenous bolus injected dose of ASI-02 is 9 mL of saline and 1 mL of air.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care to ASI-02 TTE Study | Experimental | Participants will be allocated to a saline contrast echocardiography study with agitated saline SoC, followed by a saline contrast echocardiography study with ASI-02. Receives: Drug: Agitated Saline SoC; Drug: ASI-02 |
| ASI-02 to Standard of Care TTE Study | Experimental | Participants will be allocated to a saline contrast echocardiography study with ASI-02, followed by a saline contrast echocardiography study with agitated saline SoC. Receives: Drug: Agitated Saline SoC; Drug: ASI-02 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive percentage agreement (PPA) of ASI-02 for detecting right-to-left shunt versus agitated saline SoC
Measured: Procedure through 24- to 48-hour participant follow-up visit
Negative percentage agreement (NPA) of ASI-02 for detecting right-to-left shunt versus agitated saline SoC
Measured: Procedure through 24- to 48-hour participant follow-up visit
Secondary outcomes (10)
The incidence of ASI-02-related adverse events
Measured: 24- to 48-hour participant follow-up visit
Peak opacification intensity
Measured: Procedure through 24- to 48-hour participant follow-up visit
Contrast opacification duration
Measured: Procedure through 24- to 48-hour participant follow-up visit
Positive percentage agreement (PPA) of ASI-02 for shunt detection at rest
Measured: Procedure through 24- to 48-hour participant follow-up visit
Negative percentage agreement (NPA) of ASI-02 for shunt detection at rest
Measured: Procedure through 24- to 48-hour participant follow-up visit
Positive percentage agreement (PPA) of ASI-02 for shunt detection specific to shunt sizes
Measured: Procedure through 24- to 48-hour participant follow-up visit
Negative percentage agreement (NPA) of ASI-02 for shunt detection specific to shunt sizes
Measured: Procedure through 24- to 48-hour participant follow-up visit
Test-retest reliability of agitated saline SoC
Measured: Procedure through 24- to 48-hour participant follow-up visit
Positive percentage agreement (PPA) of ASI-02 for detecting right-to-left shunt versus agitated saline SoC, using the first (nonrandomized) SoC study.
Measured: Procedure through 24- to 48-hour participant follow-up visit
Negative percentage agreement (NPA) of ASI-02 for detecting right-to-left shunt versus agitated saline SoC, using the first (nonrandomized) SoC study.
Measured: Procedure through 24- to 48-hour participant follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study start5 Nov 2025
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Right-To-Left ShuntStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- For each participant, the first two (2) injections will be agitated saline SoC (one \[1\] injection at rest, one \[1\] injection during a maneuver). Next, participants will be randomized to either receive two (2) ASI-02 injections followed by two (2) agitated saline SoC injections, or vice versa (with each pair involving an injection at rest and an injection during a maneuver).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Agitated Solutions, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bright Research Partners
- Responsible party
- Sponsor
- Investigators
- Akhil Narang, MD, Principal investigator, Northwestern Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06938347
- Sponsor's protocol ID
- ASI-CL-0301
- Acronym
- ENHANCE
- Status last verified
- Oct 2026
- First submitted
- 15 Apr 2025
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Due to the potential risks to participant privacy, the possibility of re-identification, concerns about data misuse for commercial purposes, and the potential harm to participants due to sensitive health information, IPD will not be available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Open-label, Multicenter, Randomized Crossover Trial Comparing the Safety and Efficacy of ASI-02 to Agitated Saline for Suspected Right-to-left Shunt
- ClinicalTrials.gov ID
- NCT06938347
- Acronym / sponsor ID
- ENHANCE / ASI-CL-0301
- Conditions
- Right-To-Left Shunt
- Keywords
- Saline Contrast, Saline Contrast Transthoracic Echocardiogram, Transthoracic Echocardiogram, Agitated Saline Standard of Care, Echocardiogram, Transpulmonary Shunt
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Agitated Solutions, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Bright Research Partners
- Study start
- 5 Nov 2025 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 22 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 setting of use (opacifying the right heart). The investigation will be conducted in up to 8 investigational sites in the U.S. and Canada. Participants will receive n=2 ASI-02, n=4 agitated saline SoC injections as part of a single-day imaging session, with the overall duration for study participation of 24 to 48 hours.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- For each participant, the first two (2) injections will be agitated saline SoC (one [1] injection at rest, one [1] injection during a maneuver). Next, participants will be randomized to either receive two (2) ASI-02 injections followed by two (2) agitated saline SoC injections, or vice versa (with each pair involving an injection at rest and an injection during a maneuver).
| Arm | Type | Receives |
|---|---|---|
| Standard of Care to ASI-02 TTE Study | Experimental | Drug: Agitated Saline SoC, Drug: ASI-02Participants will be allocated to a saline contrast echocardiography study with agitated saline SoC, followed by a saline contrast echocardiography study with ASI-02. |
| ASI-02 to Standard of Care TTE Study | Experimental | Drug: Agitated Saline SoC, Drug: ASI-02Participants will be allocated to a saline contrast echocardiography study with ASI-02, followed by a saline contrast echocardiography study with agitated saline SoC. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Agitated Saline SoCThe recommended initial dose of agitated saline SoC is approximately 10 mL of saline containing approximately 1 mL of air, per institutional policy, rapidly mixed (approximately 10-20 presses) to manufacture microbubbles. No additives are allowed to the saline, including blood, dextrose, or bacteriostatic saline. | Drug | ASI-02 to Standard of Care TTE Study, Standard of Care to ASI-02 TTE Study |
| ASI-02Each injection shall utilize one (1) ASI-02 product connected to one (1) pre-filled 10 mL 0.9% sodium chloride (saline) syringe. The ASI-02 investigational product will be connected to a standard luer lock connector and administered in its entirety. The intravenous bolus injected dose of ASI-02 is 9 mL of saline and 1 mL of air. | Drug | ASI-02 to Standard of Care TTE Study, Standard of Care to ASI-02 TTE Study |
Primary outcome
Positive percentage agreement (PPA) of ASI-02 for detecting right-to-left shunt versus agitated saline SoC
Time frame: Procedure through 24- to 48-hour participant follow-up visit
Negative percentage agreement (NPA) of ASI-02 for detecting right-to-left shunt versus agitated saline SoC
Time frame: Procedure through 24- to 48-hour participant follow-up visit
10 secondary outcomes
The incidence of ASI-02-related adverse events
Time frame: 24- to 48-hour participant follow-up visit
Peak opacification intensity
Time frame: Procedure through 24- to 48-hour participant follow-up visit
Contrast opacification duration
Time frame: Procedure through 24- to 48-hour participant follow-up visit
Positive percentage agreement (PPA) of ASI-02 for shunt detection at rest
Time frame: Procedure through 24- to 48-hour participant follow-up visit
Negative percentage agreement (NPA) of ASI-02 for shunt detection at rest
Time frame: Procedure through 24- to 48-hour participant follow-up visit
Positive percentage agreement (PPA) of ASI-02 for shunt detection specific to shunt sizes
Time frame: Procedure through 24- to 48-hour participant follow-up visit
Negative percentage agreement (NPA) of ASI-02 for shunt detection specific to shunt sizes
Time frame: Procedure through 24- to 48-hour participant follow-up visit
Test-retest reliability of agitated saline SoC
Time frame: Procedure through 24- to 48-hour participant follow-up visit
Positive percentage agreement (PPA) of ASI-02 for detecting right-to-left shunt versus agitated saline SoC, using the first (nonrandomized) SoC study.
Time frame: Procedure through 24- to 48-hour participant follow-up visit
Negative percentage agreement (NPA) of ASI-02 for detecting right-to-left shunt versus agitated saline SoC, using the first (nonrandomized) SoC study.
Time frame: Procedure through 24- to 48-hour participant follow-up visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: No. Due to the potential risks to participant privacy, the possibility of re-identification, concerns about data misuse for commercial purposes, and the potential harm to participants due to sensitive health information, IPD will not be available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Akhil Narang, MD principal investigator
Northwestern Medicine
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Agitated Saline SoC and ASI-02 in people with Right-To-Left Shunt, run by Agitated Solutions, Inc. at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pamela Wolfe (763-258-7027, pamela@agitatedsolutions.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive percentage agreement (PPA) of ASI-02 for detecting right-to-left shunt versus agitated saline SoC (time frame: Procedure through 24- to 48-hour participant follow-up visit). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.