CLOSURE I - Is a Prospective, Multicenter, Randomized Controlled Trial to Evaluate the Safety and Efficacy of the Starflex Septal Closure System versus Best Medical therapy in Patients with a Stroke and/or Transient Ischemic Attach due to Presumed Paradoxical Embolism Through a Patent Foramen Ovale.

There are two objectives for this study. First, to learn if the study device, when placed in the heart, will safely and effectively prevent a recurrent embolic stroke or TIA (transient ischemic attack) in patients with a patent foramen ovale (PFO). Second, to compare the study device to the best medical therapy. Best medical therapy is the use of aspirin, Coumadin, or a combination of both.

If all eligibility criteria are met, patients are randomized to study device placement or best medical therapy. Clinical follow-up for all patients is at 1, 6, 12 and 24 months post-enrollment.

• Between 18 and 61 years of age
• Occurrence of an embolic stroke or TIA (transient ischemic attack) within 6 months of study entry
• Evidence of a PFO, with right to left shunting as determined by echocardiogram
• Other eligibility criteria may apply. Please contact study coordinator.

• Occurrence of an embolic stroke from causes other than PFO.
• Unable to take aspirin.
• Presence of a coagulopathy (bleeding problem).
• Other exclusion criteria may apply. Please contact study coordinator.