PFO ACCESS Registry

N/ANo Longer AvailableNCT00583401

Abbott Medical Devices

Overview

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.

The primary objective of the PFO Access Registry is to allow access to the AMPLATZER PFO Occluder in subjects with a PFO who have already experienced at least two cryptogenic strokes due to presumed paradoxical embolism through a patent foramen ovale and who have failed conventional drug therapy.

Study Type

EXPANDED_ACCESS

Conditions

Patent Foramen Ovale Stroke

Interventions

Device closure with the AMPLATZER PFO OccluderDEVICE

Device closure with the AMPLATZER PFO Occluder

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: Patent foramen ovale (PFO); recurrent cryptogenic stroke; failed antiplatelet/anticoagulant therapy Exclusion Criteria: International normalized ration (INR) outside of 2-3; intracardiac thrombus (subjects may be enrolled after resolution of thrombus)

Data from ClinicalTrials.gov

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