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Non-Invasive Detection of Pulmonary Right-to-Left Shunts Using the SONAS Ultrasound Device
Sponsor: St. Antonius Hospital
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).
Official title: Novel Approach For The Non-Invasive Detection of Pulmonary Right-to-Left Shunts
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2026-01-07
Completion Date
2026-04-01
Last Updated
2026-02-17
Healthy Volunteers
No
Conditions
Interventions
Transcranial 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.
Locations (1)
St. Antonius Hospital
Nieuwegein, Utrecht, Netherlands