Clinical trial Recruiting at 1 site Observational Ages 18 and up

Non-invasive detection of right-to-left heart shunts

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

Run by Scripps Health · NCT07420400 · Data updated 2026-11-12

This project will test if a new handheld, battery-powered ultrasound device can detect right-to-left heart shunts in patients having a TEE with a bubble study for suspected PFO.

More Patent Foramen Ovale trials

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment75 (estimated)
SponsorScripps Health
Academic / other
Locations1 site (La Jolla, California)
StatusRecruiting
StartedJanuary 7, 2026
Main results expectedJanuary 1, 2027
Study endsMarch 1, 2027
Registry record updatedFebruary 19, 2026
Trial IDNCT07420400 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults scheduled for a clinically indicated TEE with bubble study for suspected PFO or cryptogenic stroke at the study site are ideal candidates.

Probably not a fit

Patients not undergoing TEE at this site, those with poor transthoracic acoustic windows, or those who need invasive confirmation for treatment decisions may not benefit from this device.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational protocol compares a novel battery-powered, non-invasive handheld ultrasound device with transesophageal echocardiography (TEE) with bubble study for detecting right-to-left cardiac shunts consistent with patent foramen ovale. Eligible participants are patients already scheduled for a clinically indicated TEE with contrast at Scripps Memorial Hospital La Jolla. Operators will perform point-of-care transthoracic contrast-enhanced ultrasound with the handheld device during the clinical encounter and record findings blinded to the TEE results. The study will analyze device sensitivity and concordance with the TEE bubble study to determine its ability to detect shunts.

Why it matters

Potential benefit: If successful, the device could offer a quick, non-invasive bedside test to identify right-to-left shunts and potentially reduce the need for invasive TEE in some patients.

How similar studies have gone: Prior work with transthoracic contrast ultrasound has shown variable sensitivity compared with TEE, and applying a battery-powered handheld device for this purpose is a relatively novel approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
Undergoing clinically indicated TEE with bubble study for the detection of a PFO

Where it's running

  • Scripps Memorial Hospital La Jolla
    La Jolla, California, United States
    Recruiting

Study contacts

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.