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PFO ACCESS Registry

Patent Foramen Ovale Closure With the AMPLATZER PFO OCCLUDER in Patients With Recurrent Cryptogenic Stroke Due to Presumed Paradoxical Embolism Through a Patent Foramen Ovale Who Have Failed Conventional Drug Therapy

Status
NO_LONGER_AVAILABLE
Phases
Unknown
Study type
Expanded Access
Source
ClinicalTrials.gov
Registry ID
NCT00583401
Enrollment
Unknown
Registered
2007-12-31
Start date
Unknown
Completion date
Unknown
Last updated
2019-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patent Foramen Ovale, Stroke

Keywords

PFO, stroke

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.

Detailed 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.

Interventions

DEVICEDevice closure with the AMPLATZER PFO Occluder

Device closure with the AMPLATZER PFO Occluder

Sponsors

Abbott Medical Devices
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
ALL

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)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026