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
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