Cardiovascular Research Unit
Clinical Trials and Registries

PATENT FORAMEN OVALE (PFO) CLOSURE

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

Study Summary
The purpose of this registry is to allow access to the Amplatzer PFO Occluder in patients with a PFO who have already experienced at least two strokes due to presumed embolism (blood clot blocking a brain artery) passing through a patent foramen ovale and who have failed conventional drug therapy. The Amplatzer PFO Occluder is considered an experimental device and is not yet approved by the FDA.

Enrollment Status: PENDING

RESPECT
Randomized Elevation of Recurrent Stroke comparing PFO Closure to Established Current Standard of Care Treatment

Principal Investigator
Anilkumar Mehra, M.D.

Study Coordinator
Cesar Ochoa

Study Summary
The purpose of this study is to determine if the AMPLATZER® PFO Occluder, is safe and effective in the treatment of Patent Foramen Ovale (PFO) in people who have had a stroke. In this study, the AMPLATZER PFO Occluder device is compared to medicinal therapy in preventing another stroke or death related to a PFO. The AMPLATZER PFO Occluder device is considered an experimental device and is not yet approved by the FDA.

Enrollment Status: OPEN