Non-Invasive Detection of Right-to-Left Cardiac Shunts

This study will test the sensitivity of a novel, battery-powered, non-invasive ultrasound device to detect a right-to-left shunt

Recruiting

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Key information

Conditions

Patent Foramen Ovale (PFO) Brain Diseases Cardiovascular Abnormalities Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Foramen Ovale, Patent Heart Defects, Congenital Heart Diseases Heart Septal Defects Heart Septal Defects, Atrial Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Scripps Memorial Hospital La Jolla

La Jolla, California, 92037-6837, United States

Location status: Recruiting

Location contact

Matthew J Price, MD

CONTACT

[email protected]

8582050098

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Undergoing clinically indicated TEE with bubble study for the detection of a PFO

Treatment and study plan

Point-of-care ultrasound

Diagnostic Test

Point-of-care ultrasound device to detect microbubbles in the intracranial circulation

Primary outcomes

Primary diagnostic outcome

Time frame: Intraprocedural (during TEE)

Sensitivity to detect right-to-left shunt compared with TEE as the gold standard

Study contacts

Contact information is provided by the study sponsor or research team.

Matthew J Price, MD

CONTACT

[email protected]

858-824-5269

Sponsors and collaborators

Lead sponsor

Scripps Health

Other

Collaborators

Burl Concepts, Inc.

Registry information

Official study title

Novel Approach for the Detection of Right-to-Left Cardiac Shunts

Acronym: HEADBAND

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Feb 19, 2026
Registry last updated: Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Recruiting