The purpose of this study is to determine if closing a patient’s patent foramen ovale (PFO) with the AMPLATZER PFO Occluder plus “reduced” medical therapy is superior to the current standard medical care in preventing another stroke or death related to a PFO and to evaluate the safety of the device. Current standard of care is medical treatment with blood thinning pills either anticoagulation or antiplatelet pills. A patient’s chance at either treatment is equal and will be determined from a drawing of sealed envelopes. The AMPLATZER PFO Occluder has not been approved by the FDA. “Reduced” medical therapy for the device will include plavix (blood thinner) for one month and aspirin for six months following device placement.
- Subjects with PFO who have had a cryptogenic stroke within the last 270 days, with stroke defined as follows: symptoms persisting ≥24, or symptoms persisting < 24 hours but associated with MRI or CT findings of a new cerebral stroke
Number of research visits: 11 visits including follow-ups on 1 month, 6 months, 1 year, 18 months, 2 years, and annually after until study is complete. At the 3 year visit and following visits subjects can be contacted via telephone.
Length of participation: At least 8 years
Number of EKGs: 1 at discharge for device treatment subjects and 1 at 6 month follow-up
Number of TEEs: 1 at 6 month follow-up for medical treatment subjects
Blood collection: If needed
Procedure duration: 1-2 hours