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

NCT07414446 | Recruiting

• 1 other identifier: R25.111
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 1.How accurately does SONAS detect right-to-left shunts compared to the standard TTCE test?
2. 2.Can SONAS results help tell the difference between shunts in the heart and shunts in the lungs?

Conditions

Hereditary Haemorrhagic Telangiectasia; PFO - Patent Foramen Ovale; Pulmonary Arteriovenous Malformation

Keywords

Hereditary Hemorrhagic Telangiectasisa; Pulmonary Arteriovenous Malformation; Right-to-Left Shunt; Contrast Echocardiography; Transcranial Ultrasound; Microbubbles; Patent Foramen Ovale; Cryptogenic Stroke

Outcome Measures

Primary Outcomes (2)

• 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.

  Periprocedurally

• 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.

  Periprocedurally

Secondary Outcomes (2)

• Distinguishing intracardiac from pulmonary Right-to-Left Shunts

  Periprocedurally

• Test-retest reliability of SONAS for HITS assessment

  Periprocedurally

Study Arms (1)

SONAS Ultrasound During Contrast Echocardiography

EXPERIMENTAL

This study has a single arm in which all participants undergo SONAS monitoring during a standard contrast echocardiogram (transthoracic contrast echocardiography). In this arm, adults with (possible) hereditary hemorrhagic telangiectasia or PFO who are already scheduled for a clinically indicated bubble echocardiogram have a headband with the SONAS ultrasound device examination. Agitated saline is injected into a vein as part of usual care, and the heart is imaged with echocardiography while SONAS simultaneously records ultrasound signals from the brain.

Device: Transcranial Ultrasound Device

Interventions

Transcranial Ultrasound Device 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.

Also known as: SONAS, Foqus

SONAS Ultrasound During Contrast Echocardiography

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• St. Antonius Hospital: lead
• Burl Concepts, Inc.: collaborator

Study Sites (1)

St. Antonius Hospital

Nieuwegein, Utrecht, 3435CM, Netherlands

RECRUITING

MeSH Terms

Conditions

Telangiectasia, Hereditary Hemorrhagic; Foramen Ovale, Patent; Pulmonary Arteriovenous Fistulas; Ischemic Stroke

Condition Hierarchy (Ancestors)

Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Telangiectasis; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Vascular Malformations; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Heart Septal Defects, Atrial; Heart Septal Defects; Heart Defects, Congenital; Heart Diseases; Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Martijn C. Post, Professor

  St. Antonius Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pier HJ van Veen, Medical Doctor

CONTACT

0883205336; ja.van.veen@antoniusziekenhuis.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 3, 2026
• First Posted: February 17, 2026
• Study Start: January 7, 2026
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 3 months and ending 2 years after the publication of results.
• Access Criteria: Fellow researchers interested in doing a meta-analysis of data will be able to access the IPD and supporting information. There will be access to the Study Protocol and anonymized individual patient data. Access is possible by contacting the Central Contact Person or Principal Investigator of the study.

Locations

NL (1)