NCT07420400

Brief Summary

This study will test the sensitivity of a novel, battery-powered, non-invasive ultrasound device to detect a right-to-left shunt

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
9mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress38%
Jan 2026Mar 2027

Study Start

First participant enrolled

January 7, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 12, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 19, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

February 19, 2026

Status Verified

February 1, 2026

Enrollment Period

12 months

First QC Date

February 12, 2026

Last Update Submit

February 12, 2026

Conditions

Patent Foramen Ovale (PFO)

Keywords

PFOCryptogenic strokeshunt

Outcome Measures

Primary Outcomes (1)

  • Primary diagnostic outcome

    Sensitivity to detect right-to-left shunt compared with TEE as the gold standard

    Intraprocedural (during TEE)

Study Arms (1)

Intervention

Subjects undergoing clinicially-indicated TEE for the detection of a PFO

Diagnostic Test: Point-of-care ultrasound

Interventions

Point-of-care ultrasoundDIAGNOSTIC_TEST

Point-of-care ultrasound device to detect microbubbles in the intracranial circulation

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults with suspected PFO

Undergoing clinically indicated TEE with bubble study for the detection of a PFO

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Scripps Memorial Hospital La Jolla

La Jolla, California, 92037-6837, United States

RECRUITING

MeSH Terms

Conditions

Foramen Ovale, PatentIschemic Stroke

Condition Hierarchy (Ancestors)

Heart Septal Defects, AtrialHeart Septal DefectsHeart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesStrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular Diseases

Central Study Contacts

Matthew J Price, MD

CONTACT

858-824-5269price.matthew@scrippshealth.org

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Cardiac Catheterization Laboratory, Scripps Clinic

Study Record Dates

First Submitted

February 12, 2026

First Posted

February 19, 2026

Study Start

January 7, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

February 19, 2026

Record last verified: 2026-02

Locations

US(1)