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

NCT ID: NCT06938347

Last Updated: 2025-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-05

Study Completion Date

2026-06-30

Brief Summary

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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

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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

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Right-To-Left Shunt

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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).
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors
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.

Study Groups

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Standard of Care to ASI-02 TTE Study

Participants will be allocated to a saline contrast echocardiography study with agitated saline SoC, followed by a saline contrast echocardiography study with ASI-02.

Group Type EXPERIMENTAL

Agitated Saline SoC

Intervention Type 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

Intervention Type 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

Participants will be allocated to a saline contrast echocardiography study with ASI-02, followed by a saline contrast echocardiography study with agitated saline SoC.

Group Type EXPERIMENTAL

Agitated Saline SoC

Intervention Type 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

Intervention Type 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.

Interventions

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Agitated Saline SoC

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.

Intervention Type DRUG

ASI-02

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.

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bright Research Partners

INDUSTRY

Sponsor Role collaborator

Agitated Solutions, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Akhil Narang, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern Medicine

Locations

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Northwestern University

Chicago, Illinois, United States

Site Status RECRUITING

Mayo Clinic

Rochester, Minnesota, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Pamela Wolfe

Role: CONTACT

Phone: 763-258-7027

Email: [email protected]

Rebecca Zickert

Role: CONTACT

Phone: 612-345-4544

Email: [email protected]

Other Identifiers

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ASI-CL-0301

Identifier Type: -

Identifier Source: org_study_id