Influence of Position on Detection of Patent Foramen Oval... | NCT02383836

Studies
Influence of Position on Detection of Patent Foramen Ovale by Simultaneous Transesophageal Echo and Transcranial Doppler

NCT02383836

Sponsor

Hillel Yaffe Medical Center

Status

Unknown status

Last Update Posted

Mar 9, 2015Estimated

Enrollment

100Estimated

Phase

Not provided

Conditions

Patent Foramen Ovale

Interventions

Not provided

Countries

Israel

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

Mar 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2015

Primary Completion Date

Mar 2016Estimated

Completion Date

Aug 2016Estimated

First Submitted Date

Feb 23, 2015

First Submission Date that Met QC Criteria

Mar 3, 2015

First Posted Date

Mar 9, 2015Estimated

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

Mar 3, 2015

Last Update Posted Date

Mar 9, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Patients will have simultaneous Transesophageal Echo (TEE) and Transcranial Doppler (TCD) performed and a comparison of timing, sensitivity and intensity of intravenously injected bubbles will be determined.

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

100Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Bubble Detection	The amount of time until bubbles are detected will be measured	3 minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients needing a TEE evaluation to rule out a cardiac source of brain emboli

Exclusion Criteria:

Patients unable to comply with protocol requirements
Patients unable or unwilling to sign informed consent

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

Patients referred for a TEE with bubble injection to rule out a cardiac source of brain emboli following an acute neurological embolic event.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
David S Blondheim, MD	Contact	972-463-04488		davidb@hy.health.gov.il

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hillel Yaffe Medical Center		Hadera		38100	Israel

Condition Browse Module

MeSH Terms

ID	Term
D054092	Foramen Ovale, Patent

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