Clinical Trial: PFO ACCESS Registry

Study Status: Available
Recruit Status: Available
Study Type: Expanded Access

Official Title: Patent Foramen Ovale Closure With the AMPLATZER PFO OCCLUDER in Patients With Recurrent Cryptogenic Stroke Due to Presumed Paradoxical Embolism Through a Patent Foramen Ov

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 Summary: 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.
Sponsor: St. Jude Medical

Current Primary Outcome:

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: St. Jude Medical

Dates:
Date Received: December 21, 2007
Date Started:
Date Completion:
Last Updated: July 20, 2016
Last Verified: July 2016