RecruitingNot ApplicableNCT07414446

Non-Invasive Detection of Pulmonary Right-to-Left Shunts Using the SONAS Ultrasound Device

Novel Approach For The Non-Invasive Detection of Pulmonary Right-to-Left Shunts

Sponsor

St. Antonius Hospital

Enrollment

40 participants

Start Date

Jan 7, 2026

Study Type

INTERVENTIONAL

Conditions

Hereditary Haemorrhagic Telangiectasia Pulmonary Arteriovenous Malformation PFO - Patent Foramen Ovale

Summary

The goal of this clinical trial is to learn how well the SONAS ultrasound device can detect right-to-left shunts of adults with hereditary hemorrhagic telangiectasia (HHT) who are already scheduled for a contrast bubble echocardiogram (TTCE). The main questions it aims to answer are: 1. How accurately does SONAS detect right-to-left shunts compared to the standard TTCE test? 2. Can SONAS results help tell the difference between shunts in the heart and shunts in the lungs? Participants will wear a headband with the SONAS device on the head while they undergo their routine TTCE bubble test. They will receive the usual contrast (agitated saline) through a vein, and both SONAS and TTCE signals will be recorded at the same time. There will be one examination in rest, and one during a breathing exercise (the Valsalva manoeuvre).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Transcranial Ultrasound Device for people with hereditary haemorrhagic telangiectasia, pfo - patent foramen ovale, and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICETranscranial Ultrasound Device

The intervention is the SONAS ultrasound device used during a routine bubble echocardiogram. A battery-powered unit connects to a headset with two ultrasound sensors placed in front of the ears. The device does not deliver contrast or drugs; it records ultrasound signals in the brain while standard agitated saline is injected and the heart is imaged. SONAS analyzes bubble-related signals and calculates a numeric score to evaluate right-to-left shunts without changing the usual echocardiography protocol.