Patent Foramen Ovale (PFO)HEADBANDNCT07420400
Non-Invasive Detection of Right-to-Left Cardiac Shunts
An observational study of Patent Foramen Ovale (PFO), run by Scripps Health at 1 site in United States.
Trial summary
This study will test the sensitivity of a novel, battery-powered, non-invasive ultrasound device to detect a right-to-left shunt Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patent Foramen Ovale (PFO)
- What is being tested?
- Point-of-care ultrasound
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jan 2026to 1 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with suspected PFO
Undergoing clinically indicated TEE with bubble study for the detection of a PFO
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Scripps Memorial Hospital La Jolla
La Jolla, California, 92037-6837
Matthew J Price, MD, 8582050098, price.matthew@scrippshealth.org
About this study
Official title: 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
- Conditions
- Patent Foramen Ovale (PFO)
- Being tested
- Point-of-care ultrasound
- Keywords
- PFO, Cryptogenic stroke, shunt
- Medical subject headings
- Foramen Ovale, Patent, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Point-of-care ultrasoundDiagnostic test
Point-of-care ultrasound device to detect microbubbles in the intracranial circulation
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Subjects undergoing clinicially-indicated TEE for the detection of a PFO Receives: Diagnostic Test: Point-of-care ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary diagnostic outcome
Sensitivity to detect right-to-left shunt compared with TEE as the gold standard
Measured: Intraprocedural (during TEE)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start7 Jan 2026
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patent Foramen Ovale (PFO)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Scripps Health
- Sponsor type
- University, hospital or other
- Collaborators
- Burl Concepts, Inc.
- Responsible party
- Principal investigator, Matthew J Price, Scripps Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07420400
- Sponsor's protocol ID
- 25-8657
- Acronym
- HEADBAND
- Status last verified
- Feb 2026
- First submitted
- 12 Feb 2026
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Pending
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Approach for the Detection of Right-to-Left Cardiac Shunts
- ClinicalTrials.gov ID
- NCT07420400
- Acronym / sponsor ID
- HEADBAND / 25-8657
- Conditions
- Patent Foramen Ovale (PFO)
- Keywords
- PFO, Cryptogenic stroke, shunt
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Scripps HealthUniversity, hospital or other
- Collaborators
- Burl Concepts, Inc.
- Study start
- 7 Jan 2026 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 19 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will test the sensitivity of a novel, battery-powered, non-invasive ultrasound device to detect a right-to-left shunt
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | – | Diagnostic Test: Point-of-care ultrasoundSubjects undergoing clinicially-indicated TEE for the detection of a PFO |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with suspected PFO
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Point-of-care ultrasoundPoint-of-care ultrasound device to detect microbubbles in the intracranial circulation | Diagnostic test | Intervention |
Primary outcome
Primary diagnostic outcome
Time frame: Intraprocedural (during TEE)
Sensitivity to detect right-to-left shunt compared with TEE as the gold standard
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- Individual participant dataSharing planned: Undecided. Pending
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patent Foramen Ovale (PFO), run by Scripps Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matthew J Price, MD (858-824-5269, price.matthew@scrippshealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary diagnostic outcome (time frame: Intraprocedural (during TEE)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.