Emergency/Compassionate Use PFO Occluder | NCT00584064

Studies
Emergency/Compassionate Use PFO Occluder

NCT00584064

Sponsor

Abbott Medical Devices

Status

Approved for marketing

Last Update Posted

Apr 11, 2019Actual

Enrollment

Not provided

Phase

Not provided

Conditions

Patent Foramen Ovale
PFO

Interventions

Device closure with the AMPLATZER PFO Occluder

Countries

Not provided

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 2019

Overall Recruitment Status or Expanded Access Status

Approved for marketing

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Dec 20, 2007

First Submission Date that Met QC Criteria

Dec 31, 2007

First Posted Date

Jan 2, 2008Estimated

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 9, 2019

Last Update Posted Date

Apr 11, 2019Actual

Design Module

Study Type

Expanded Access

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 provided

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Device closure with the AMPLATZER PFO Occluder	Device	Device closure with the AMPLATZER PFO Occluder

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Emergency/compassionate use for patients not meeting the inclusion criteria for the AMPLATZER PFO Access Registry.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

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