Actively Recruiting
Novel Approach for the Detection of Right-to-Left Cardiac Shunts
Led by Scripps Health · Updated on 2026-02-19
75
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
Sponsors
S
Scripps Health
Lead Sponsor
B
Burl Concepts, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a new, battery-powered, non-invasive ultrasound device to detect right-to-left cardiac shunts, specifically patent foramen ovale (PFO). The study aims to test how sensitive this novel ultrasound device is compared to the standard clinical method. This observational research is sponsored by Scripps Health and focuses on improving diagnostic approaches for PFO detection. Participants in this study will undergo a clinically indicated transesophageal echocardiogram (TEE) with a bubble study, which is the current method for detecting PFO. During this procedure, the novel point-of-care ultrasound device will be used to detect microbubbles in the intracranial circulation as an additional diagnostic tool. The study does not involve treatment but focuses on comparing diagnostic techniques during the TEE. Participants will be monitored during the TEE procedure to assess the ultrasound device's performance. The primary outcome is the diagnostic result recorded intraprocedurally during the TEE. Since this is an observational study, there are no treatment visits or long-term follow-up periods. Participation involves undergoing the TEE procedure as part of usual care, with the added use of the ultrasound device for research purposes.
CONDITIONS
Brief Title
Non-Invasive Detection of Right-to-Left Cardiac Shunts
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Undergoing clinically indicated transesophageal echocardiogram (TEE) with bubble study for detection of patent foramen ovale (PFO)
- Aged 18 years or older
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day
Participants undergo a clinically indicated transesophageal echocardiogram (TEE) with bubble study and point-of-care ultrasound to detect right-to-left cardiac shunts.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Scripps Memorial Hospital La Jolla
La Jolla, California, United States, 92037-6837
Actively Recruiting
Research Team
M
Matthew J Price, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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