Comparing the Safety and Efficacy of ASI-02 to Agitated Saline for Suspected Right-to-left Shunt

NCT06938347 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: ASI-CL-0301
• Study Type: interventional
• Target: 300
• Locations: 2 countries
• Sites: 5

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.

Conditions

Right-To-Left Shunt

Keywords

Saline Contrast; Saline Contrast Transthoracic Echocardiogram; Transthoracic Echocardiogram; Agitated Saline Standard of Care; Echocardiogram; Transpulmonary Shunt

Outcome Measures

Primary Outcomes (2)

• Positive percentage agreement (PPA) of ASI-02 for detecting right-to-left shunt versus agitated saline SoC

  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

  Procedure through 24- to 48-hour participant follow-up visit

Secondary Outcomes (10)

• The incidence of ASI-02-related adverse events

  24- to 48-hour participant follow-up visit

• Peak opacification intensity

  Procedure through 24- to 48-hour participant follow-up visit

• Contrast opacification duration

  Procedure through 24- to 48-hour participant follow-up visit

• Positive percentage agreement (PPA) of ASI-02 for shunt detection at rest

  Procedure through 24- to 48-hour participant follow-up visit

• Negative percentage agreement (NPA) of ASI-02 for shunt detection at rest

  Procedure through 24- to 48-hour participant follow-up visit

Study Arms (2)

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.

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.

Drug: Agitated Saline SoC; Drug: ASI-02

Interventions

Agitated Saline SoC DRUG

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-02 to Standard of Care TTE Study; Standard of Care to ASI-02 TTE Study

ASI-02 DRUG

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.

ASI-02 to Standard of Care TTE Study; Standard of Care to ASI-02 TTE Study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Agitated Solutions, Inc.: lead
• Bright Research Partners: collaborator

Study Sites (5)

Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

Jackson Heart Clinic

Jackson, Mississippi, 39216, United States

RECRUITING

NYU Langone Health

New York, New York, 10016, United States

RECRUITING

Toronto General

Toronto, M5G 2C4, Canada

RECRUITING

Study Officials

• Akhil Narang, MD

  Northwestern Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pamela Wolfe

CONTACT

763-258-7027; pamela@agitatedsolutions.com

Rebecca Zickert

CONTACT

612-345-4544; rebecca.zickert@brightresearch.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This is an open-label study; therefore, blinding procedures are not necessary for site personnel or participants. Blinded assessment of the primary efficacy endpoint will be completed by the core lab.
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: April 15, 2025
• First Posted: April 22, 2025
• Study Start: November 5, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: December 3, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (4); CA (1)