Safety and Effectiveness Study of the Solysafe Septal Occluder in Patients With Atrial Septum Defect and Patent Foramen Ovale
Safety and Effectiveness Study of the Solysafe Septal Occluder in Patients With Atrial Septum Defect and Patent Foramen Ovale
This is a prospective multicenter clinical study to evaluate the safety and effectiveness of
 an intracardiac septal closure device in patients with atrial septum defect (ASD) and patent
 foramen ovale (PFO).
Inclusion Criteria:

 -  ASD

 -  PFO with a medical history of cryptogenic stroke due to presumed paradoxical embolism
 caused by a PFO

 Exclusion Criteria:

 -  Criteria that exclude catheterization (e.g. size too small, disseminated intravascular
 coagulopathy (DIC), high risk of bleeding such as coagulation or clotting disorders)