Non-invasive detection of right-to-left heart shunts
Novel Approach for the Detection of Right-to-Left Cardiac Shunts
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 |
|---|---|
| Enrollment | 75 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Scripps Health Academic / other |
| Locations | 1 site (La Jolla, California) |
| Trial ID | NCT07420400 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
Show full inclusion / exclusion criteria
Undergoing clinically indicated TEE with bubble study for the detection of a PFO
Where this trial is running
La Jolla, California
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.