NCT00583401

Brief Summary

Closure of Patent Foramen Ovale with the AMPLATZER® PFO OCCLUDER in patients with at least two cryptogenic strokes due to presumed paradoxical embolism through a patent foramen ovale and who have failed conventional therapy.

Trial Health

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 21, 2007

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 31, 2007

Completed
Last Updated

February 4, 2019

Status Verified

January 1, 2019

First QC Date

December 21, 2007

Last Update Submit

January 31, 2019

Conditions

Patent Foramen OvaleStroke

Keywords

PFOstroke

Interventions

Device closure with the AMPLATZER PFO OccluderDEVICE

Device closure with the AMPLATZER PFO Occluder

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patent foramen ovale (PFO); recurrent cryptogenic stroke; failed antiplatelet/anticoagulant therapy

You may not qualify if:

  • International normalized ration (INR) outside of 2-3; intracardiac thrombus (subjects may be enrolled after resolution of thrombus)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Foramen Ovale, PatentStroke

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
expanded access
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2007

First Posted

December 31, 2007

Last Updated

February 4, 2019

Record last verified: 2019-01