ASI-02 for Heart Defects

(ENHANCE Trial)

This trial tests a new treatment called ASI-02 for individuals with certain heart defects that cause improper blood flow through the heart. The researchers aim to determine if ASI-02 outperforms the current standard treatment, which uses agitated saline during specialized heart scans. Participants will receive both treatments in varying orders to compare results. Doctors have advised potential participants to undergo this type of heart scan due to suspected issues like an atrial septal defect (a hole in the heart). As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team to get a clear answer.

Research shows that ASI-02 is being compared to the usual agitated saline treatment for evaluating heart defects. In studies, up to 300 people participated to assess the safety of ASI-02. The main goal was to determine if it can safely help doctors identify heart shunts (abnormal blood flow paths) as effectively as the standard method.

This is a phase 3 trial, indicating that ASI-02 has already undergone earlier safety testing. Phase 3 trials aim to confirm a treatment's safety and effectiveness in a larger group. Although specific side effects are not detailed here, reaching this trial phase suggests ASI-02 has generally been well-tolerated.

Researchers are excited about ASI-02 for heart defects because it aims to enhance the imaging quality in echocardiography. Unlike traditional agitated saline used in standard care, ASI-02 may provide clearer and more detailed heart images, which can improve diagnosis accuracy. This could lead to better treatment plans for patients with heart defects, making it a promising innovation in cardiac imaging.

This trial will compare ASI-02 with the standard method using agitated saline for detecting heart defects, especially right-to-left shunts. Research has shown that ASI-02 aims to match the effectiveness of agitated saline in identifying these heart issues during echocardiograms, which are heart imaging tests. Early findings suggest that ASI-02 enhances the visibility of these shunts, potentially offering a clearer view during the heart scan. While more detailed results are still being collected, initial outcomes are promising and indicate that ASI-02 could serve as a reliable alternative to the current standard.¹⁶⁷⁸⁹