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SONAS

Novel Approach For The Non-Invasive Detection of Pulmonary Right-to-Left Shunts (SONAS) - Value of SONAS in detection of right-to-left shunting

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON58201
Enrollment
40
Registered
2025-10-23
Start date
2026-01-07
Completion date
Unknown
Last updated
2026-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The study population will mainly consist of patient with confirmed or suspected Hereditary Haemorrhagic Telangiectasia (HHT), also called Osler-Weber-Rendu disease (ROW). Some patients will be studied because they are screened for HHT, but will prove not to have the disease. HHT

Interventions

Participants undergo standard-of-care TTCE with agitated saline administration during rest and Valsalva maneuver. Simultaneously, the SONAS headset acquires cerebral perfusion data for 45 seconds para
the only addition is SONAS headset placement.&nbsp

Sponsors

St. Antonius Ziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients with a suspicion or confirmed diagnosis of HHT who are screened for the presence of pulmonary right-to-left shunting by TTCE. Patients must be = 18 years.

Exclusion criteria

Exclusion criteria: Pregnancy

Design outcomes

Primary

MeasureTime frame
1. 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.2. Diagnostic accuracy (sensitivity and specificity) of SONAS for detection of clinically significant RLS (=grade 2 on TTCE) at different HITS Density Score thresholds.

Secondary

MeasureTime frame
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. 2. Test-retest reliability of SONAS for HITS assessment using Intraclass Correlation Coefficient.

Countries

Netherlands

Contacts

Public ContactP.H.J. Veen

St. Antonius Ziekenhuis

ja.van.veen@antoniusziekenhuis.nl0883205336

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Apr 17, 2026