Non-Invasive Detection of Right-to-Left Cardiac Shunts (HEADBAND)

February 12, 2026 updated by: Matthew J Price, Scripps Health

Novel Approach for the 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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adults with suspected PFO

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Intervention
Subjects undergoing clinicially-indicated TEE for the detection of a PFO
Diagnostic test: Point-of-care ultrasound
Point-of-care ultrasound device to detect microbubbles in the intracranial circulation

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Scripps Health

Collaborators

Burl Concepts, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 7, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

February 12, 2026

First Submitted That Met QC Criteria

February 12, 2026

First Posted (Actual)

February 19, 2026

Study Record Updates

Last Update Posted (Actual)

February 19, 2026

Last Update Submitted That Met QC Criteria

February 12, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-8657

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Pending

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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