Non-Invasive Detection of Right-to-Left Cardiac Shunts
ConditionPatent Foramen Ovale (PFO)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorScripps Health
About this trial
This study will test the sensitivity of a novel, battery-powered, non-invasive ultrasound device to detect a right-to-left shunt
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
Adults with suspected PFO
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Point-of-care ultrasound
Diagnostic testPoint-of-care ultrasound device to detect microbubbles in the intracranial circulation
Treatment groups
75 Participants
are divided into 1 treatment groupGroup A: Intervention1 intervention
Trial outcomes
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)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Scripps Health
Lead sponsor
Burl Concepts, Inc.
Collaborator
Source ClinicalTrials.gov