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

Inclusion Criteria3

Age 18 years or older.
Suspected or confirmed hereditary hemorrhagic telangiectasia (HHT).
Incidentally: Patients who have experienced cryptogenic stroke

Exclusion Criteria4

Pregnancy or breastfeeding.
Known or suspected fracture(s) of the temporal / parietal skull bones, or with open skin injuries in the anatomical area of the temporal / parietal lobes.
Patients with known metal skull implants in the anatomical area of the temporal / parietal bones, or with anatomical formation of the head or ear tha may interfere with proper headset placement.
Patients with known allergies or reactions to parabens, which are present in the gel pad material of the applied part.

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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.