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.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 75 (estimated) |
| Sponsor | Scripps Health Academic / other |
| Locations | 1 site (La Jolla, California) |
| Status | Recruiting |
| Started | January 7, 2026 |
| Main results expected | January 1, 2027 |
| Study ends | March 1, 2027 |
| Registry record updated | February 19, 2026 |
| Trial ID | NCT07420400 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
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Scripps Memorial Hospital La Jolla
La Jolla, California, United States Recruiting
Study contacts
- Study coordinator: Matthew J Price, MD
- Email: price.matthew@scrippshealth.org
- Phone: 858-824-5269
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Pulmonary embolism with right-to-left heart or lung shunts
This project will see if people with an acute pulmonary embolism who also have a right-to-left shunt (like a PFO or ASD) are more likely to have a stroke than PE patients without a shunt.
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PFO closure versus blood thinners to prevent repeat stroke in older adults
This study will test whether closing a patent foramen ovale or taking direct oral anticoagulants better prevents repeat strokes in adults over 60 with PFO-related embolic stroke.
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Investigating cerebral microembolization in patients with PFO closure
This study is trying to see if patients with a heart condition called PFO who undergo a closure procedure experience tiny blood clots in the brain and how these might relate to existing clots in the heart.
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P3 Occluder System for closing a heart opening (PFO) after stroke
We are testing the P3 Occluder System to see if it safely and effectively closes a patent foramen ovale in adults who had a stroke related to their heart opening.
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Non-invasive detection of right-to-left shunts with the SONAS headband
This will test whether the SONAS headband can find right-to-left shunts in adults with hereditary hemorrhagic telangiectasia (HHT) who are already having a bubble heart ultrasound (TTCE).
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Percutaneous repair of the atrial septum using the P3 Occluder System for PFO closure
This trial tests the P3 Occluder System to close a patent foramen ovale (PFO) in adults 18–65 who have had a stroke that may be linked to their PFO.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.