This study is comparing a new product called ASI-02 to the standard method (agitated saline) for finding a suspected right-to-left shunt. A right-to-left shunt is when blood flows in an abnormal direction within your heart or blood vessels. Both ASI-02 and agitated saline are used during a special ultrasound of your heart (saline contrast transthoracic echocardiogram, or TTE) to help doctors see this shunt. The study wants to see how well ASI-02 works compared to agitated saline and if it is safe. You might be able to join if you are at least 18 years old, are suspected of having a right-to-left shunt, and are scheduled for a saline contrast TTE. Pregnant or breastfeeding women cannot participate. The study will be considered successful if ASI-02 accurately detects shunts as well as agitated saline does. The current recruitment status is unclear.

Study design

This is a Phase 3, multi-center, open-label, blinded, crossover study involving up to 300 participants. Each participant will receive both ASI-02 and agitated saline in a randomized order.

What's involved

You will have a single-day imaging session where you receive two injections of ASI-02 and four injections of agitated saline. Your total participation will last 24 to 48 hours.

Compensation

Not stated in the trial record.

Follow-up

Participants will be followed for 24 to 48 hours after the procedure.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.