Non-Invasive Detection of Right-to-Left Cardiac Shunts | NCT07420400

Studies
Non-Invasive Detection of Right-to-Left Cardiac Shunts

NCT07420400

Sponsor

Scripps Health

Status

Recruiting

Last Update Posted

Feb 19, 2026Actual

Enrollment

75Estimated

Phase

Not provided

Conditions

Patent Foramen Ovale (PFO)

Interventions

Point-of-care ultrasound

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 7, 2026Actual

Primary Completion Date

Jan 1, 2027Estimated

Completion Date

Mar 1, 2027Estimated

First Submitted Date

Feb 12, 2026

First Submission Date that Met QC Criteria

Feb 12, 2026

First Posted Date

Feb 19, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 12, 2026

Last Update Posted Date

Feb 19, 2026Actual

Name	Class
Burl Concepts, Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Yes

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

75Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention		Subjects undergoing clinicially-indicated TEE for the detection of a PFO	Diagnostic Test: Point-of-care ultrasound

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Point-of-care ultrasound	Diagnostic Test	Point-of-care ultrasound device to detect microbubbles in the intracranial circulation	Intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Primary diagnostic outcome	Sensitivity to detect right-to-left shunt compared with TEE as the gold standard	Intraprocedural (during TEE)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adults with suspected PFO

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Matthew J Price, MD	Contact	858-824-5269		price.matthew@scrippshealth.org

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Scripps Memorial Hospital La Jolla	Recruiting	La Jolla	California	92037-6837	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Pending

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D054092	Foramen Ovale, Patent
D000083242	Ischemic Stroke

Ancestor Terms

ID	Term
D006344	Heart Septal Defects, Atrial
D006343	Heart Septal Defects
D006330	Heart Defects, Congenital
D018376	Cardiovascular Abnormalities

Browse Leaves

Not provided

Browse Branches

Not provided