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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07420400

Acronym

HEADBAND

Enrollment

Registered

2026-02-19

Start date

2026-01-07

Completion date

2027-03-01

Last updated

2026-02-19

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

Conditions

Patent Foramen Ovale (PFO)

Keywords

PFO, Cryptogenic stroke, shunt

Brief summary

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

Interventions

DIAGNOSTIC_TESTPoint-of-care ultrasound

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

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Primary diagnostic outcome	Intraprocedural (during TEE)	Sensitivity to detect right-to-left shunt compared with TEE as the gold standard

Countries

United States

Contacts

CONTACTMatthew J Price, MD

price.matthew@scrippshealth.org858-824-5269

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026