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RecruitingNCT07420400HEADBANDUpdated Feb 19, 2026

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

An observational study in Patent Foramen Ovale (PFO), sponsored by Scripps Health. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-19.

Sponsored by Scripps Health · Observational

From the registry’s dates

  • Started Jan 2026; still recruiting 9 months later.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
75
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Patent Foramen Ovale (PFO)

Keywords

  • PFO
  • Cryptogenic stroke
  • shunt
03

In context

Foramen Ovale, Patent

134 studies on the registry are indexed under Foramen Ovale, Patent; 46 are open to participants now.

This study's planned enrollment of 75 is below the median of 226 across 57 observational studies indexed under Foramen Ovale, Patent.

Browse Foramen Ovale, Patent studies →

Lead sponsor

Scripps Health is the lead sponsor of 45 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adults with suspected PFO

Eligibility criteria

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

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
75 participants (estimated)
Patient registry
No

Groups and cohorts

  • Intervention

    Subjects undergoing clinicially-indicated TEE for the detection of a PFO

    Diagnostic Test: Point-of-care ultrasound

Interventions

  • Diagnostic testPoint-of-care ultrasound

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

06

What researchers measure

Primary outcomes

  1. Primary diagnostic outcome

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

    Time frame: Intraprocedural (during TEE)

07

Study locations

1 of 1 sites recruiting
  • Scripps Memorial Hospital La Jolla
    La Jolla, California 92037-6837, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided — Pending

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 19, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07420400
Lead sponsor
Scripps Health
Collaborators
Burl Concepts, Inc.
Responsible party
Matthew J Price (Director, Cardiac Catheterization Laboratory, Scripps Clinic, Scripps Health) — Principal investigator
First posted
Feb 19, 2026
Start date
Jan 7, 2026
Primary completion
Jan 1, 2027 (estimated)
Completion
Mar 1, 2027 (estimated)
Last update
Feb 19, 2026

Study contacts

Matthew J Price, MD
Contact
price.matthew@scrippshealth.org
858-824-5269

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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