PFO ACCESS Registry

Abbott

Status

Conditions: Stroke; Patent Foramen Ovale

Treatments: Device: Device closure with the AMPLATZER PFO Occluder

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT00583401

G060145

AGA-011

Details and patient eligibility

About

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.

Full description

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.

Sex: All

Volunteers: No Healthy Volunteers

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)