Clinical Trial Fact Sheet

Trial design
Prospective multi-center randomized clinical trial to evaluate safety and efficacy.

Patient population
Patients 18-60 years of age with a cryptogenic stroke and PFO. Patients need to be enrolled within 270 days of their last stroke.

Randomization arms
Closure of the PFO with the AMPLATZER^® PFO Occluder or treatment with the current medical standard-of-care.

Baseline testing
Medical history; neurology evaluation; electrocardiogram (ECG) or Holter study; transesophageal echocardiography (TEE) with bubble study; magnetic resonance imaging (MRI) or cat scan (CT); magnetic resonance angiography (MRA), duplex sonography, CT angiography or contrast angiography; pregnancy test (pre-menopausal women and women of child bearing potential); and blood tests.

Follow-up
Patients will be evaluated pre-discharge (device only), at 1 month, 6 months, 12 months, 18 months, 24 months and annually through the post-market approval period.

End points
Recurrence of nonfatal stroke, post-randomization death and fatal ischemic stroke.

Where can I read more on the need for additional scientific understanding of PFO Closure for Strokes?
A science advisory on Percutaneous Device Closure of Patent Foramen Ovale for Secondary Stroke Prevention was recently published in Circulation. The May 2009 science advisory from The American Heart Association/American Stroke Association and the American College of Cardiology Foundation calls for the completion of randomized clinical trials. In addition, the American Academy of Neurology affirms the value of the science advisory.