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).
Age 18 years or older.
Suspected or confirmed hereditary hemorrhagic telangiectasia (HHT).
Incidentally: Patients who have experienced cryptogenic stroke
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.
Single group
Transcranial Ultrasound Device
DeviceThe 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.
Capability of detecting Right-to-Left Shunts
Device capability of detecting High Intensity Transient Signals (HITS) using SONAS in presence of RLS, as confirmed by reference method TTCE. SONAS output is expressed as maximum HITS Density Score (0-100%). TTCE outcome is assessed by RLS grade (0-3), maximum microbubble count in left ventricle, and corrected change in echo density.
Diagnostic accuracy
Diagnostic accuracy (sensitivity and specificity) of SONAS for detection of clinically significant RLS (≥grade 2 on TTCE) at different HITS Density Score thresholds.
Distinguishing intracardiac from pulmonary Right-to-Left Shunts
SONAS capability to distinguish intracardiac from pulmonary RLS based on time delay between contrast administration and first HITS occurrence, and difference in HITS Density Score between rest and Valsalva maneuver.
Test-retest reliability of SONAS for HITS assessment
Test-retest reliability of SONAS for HITS assessment using Intraclass Correlation Coefficient.
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St. Antonius Hospital
Lead sponsor
Burl Concepts, Inc.
Collaborator
