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

July 2, 2026 updated by: Agitated Solutions, Inc.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Canada
      • Toronto, Canada, M5G 2C4
        • Recruiting
        • Toronto General
        • Principal Investigator:
          • Wendy Tsang, MD
  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern University
        • Principal Investigator:
          • Akhil Narang, MD
      • Chicago, Illinois, United States, 60657
        • Recruiting
        • AH Illinois Masonic Center
        • Principal Investigator:
          • Sorin Danciu, MD
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic
        • Principal Investigator:
          • Sunil Mankad, MD
      • Saint Cloud, Minnesota, United States, 56303
        • Recruiting
        • CentraCare
        • Principal Investigator:
          • Timothy Schuchard, MD
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • Recruiting
        • Jackson Heart Clinic
        • Principal Investigator:
          • William Crowder, MD
    • New York
      • New York, New York, United States, 10016
        • Recruiting
        • NYU Langone Health
        • Principal Investigator:
          • Daniel Bamira, MD
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Recruiting
        • Aurora St. Lukes Medical Center
        • Principal Investigator:
          • Renuka Jain, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Drug: 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.
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.
Experimental: 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.
Drug: 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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
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
Procedure through 24- to 48-hour participant follow-up visit

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
The incidence of ASI-02-related adverse events
Time Frame: 24- to 48-hour participant follow-up visit
24- to 48-hour participant follow-up visit
Peak opacification intensity
Time Frame: Procedure through 24- to 48-hour participant follow-up visit
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
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
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
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
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
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
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
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
Procedure through 24- to 48-hour participant follow-up visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Agitated Solutions, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Bright Research Partners

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Akhil Narang, MD, Northwestern Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 5, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 15, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 15, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 22, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ASI-CL-0301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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