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

Conditions

• Right-To-Left Shunt

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

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 — 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.

Study Details

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.

Key Dates

Start date

Nov 5, 2025

Status verified

Jun 2026

Primary completion

Jun 30, 2026

Completion

Jun 30, 2026

Study Design

Enrollment

300 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

DIAGNOSTIC

Arms

• 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.
• 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.

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 ]

Central Contacts

• Pamela Wolfe
  763-258-7027
  [email protected]
• Rebecca Zickert
  612-345-4544
  [email protected]

Locations (5)

Find similar trials in Chicago, IL

Related Studies

• Pulmonary Embolism and Right-to-Left Shunts
  Recruiting · Tufts Medical Center · Boston, Massachusetts