AMPLATZER PFO Occluder Post Approval Study
Clinical Trial Information
Trial Contact: Marquart,Vashnie; Ngo, George M.; Cox, Caitlin L
Assessing the 30-day rate of device- or procedure-related serious adverse events including those that led to death. And to demonstrate that the AMPLATZERTM PFO Occluder is effective by assessing the rate of recurrent ischemic stroke through 5 years.
1. History of PFO
2. CVA within 270 days
3. Cryptogenic Stroke