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PFO ACCESS Registry

NCT ID: NCT00583401

Last Updated: 2019-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NO_LONGER_AVAILABLE

Study Classification

EXPANDED_ACCESS

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Patent Foramen Ovale Stroke

Interventions

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Device closure with the AMPLATZER PFO Occluder

Device closure with the AMPLATZER PFO Occluder

Intervention Type DEVICE

Eligibility Criteria

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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)
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott Medical Devices

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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G060145

Identifier Type: -

Identifier Source: secondary_id

AGA-011

Identifier Type: -

Identifier Source: org_study_id

NCT00557479

Identifier Type: -

Identifier Source: nct_alias

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