GORE® Septal Occluder European Union Clinical Evaluation | NCT01605851

Studies
GORE® Septal Occluder European Union Clinical Evaluation

NCT01605851

Sponsor

W.L.Gore & Associates

Status

Completed

Last Update Posted

Apr 24, 2014Estimated

Enrollment

150Actual

Phase

Not Applicable

Conditions

Closure; Foramen Ovale

Interventions

Closure, Foramen Ovale

Countries

Denmark
Germany
Italy
Sweden
United Kingdom

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

Apr 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2012

Primary Completion Date

Jan 2014Actual

Completion Date

Apr 2014Actual

First Submitted Date

May 18, 2012

First Submission Date that Met QC Criteria

May 24, 2012

First Posted Date

May 25, 2012Estimated

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

Apr 22, 2014

Last Update Posted Date

Apr 24, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

The primary objective of this study is to evaluate clinical success and performance of the GORE® Septal Occluder when used for percutaneous, transcatheter closure of Patent Foramen Ovale (PFO).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Closure, Foramen Ovale	Other	Patients undergoing device closure of PFO	Device: Closure, Foramen Ovale

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Closure, Foramen Ovale	Device		Closure, Foramen Ovale

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To evaluate clinical success and performance of the GORE® Septal Occluder when used for percutaneous, transcatheter closure of PFO	The primary endpoint for the study is composite Clinical Success evaluated at 6 months post-index procedure	6 months

Secondary Outcomes

Measure	Description	Time Frame
Additional Clinical Success evaluated during the procedure and 6 months post-procedure	Technical Success, Procedure Success, Closure Success	6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Subjects with a PFO less than or equal to 17mm

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aarhus University Hospital		Aarhus			Denmark
Rigshospitalet