Safety and Efficacy of the GORE® Septal Occluder to Treat Ostium Secundum Atrial Septal Defects
Safety and Efficacy of the GORE® Septal Occluder to Treat Ostium Secundum Atrial Septal Defects
The primary objective of the GORE® Septal Occluder Study is to evaluate the safety and
 efficacy of the occluder device in the treatment of transcatheter closure of ostium secundum
 atrial septal defects (ASDs). The data obtained in this study will evaluate this next
 generation device as compared to outcomes of prior studies conducted with the GORE® HELEX®
 Septal Occluder.
Ostium secundum atrial septal defects present as a persistent communication between the atria
 and are a common congenital cardiac anomaly accounting for approximately 10% of all
 congenital heart disease. They are one of the most common congenital heart defects to present
 in adulthood. Untreated, ASDs produce right heart volume overload and progressive impairment
 over time, including reduced aerobic capacity, atrial dysrhythmias, congestive heart failure,
 pulmonary hypertension, and potential paradoxical embolism. In the U.S. alone it is estimated
 that approximately 10,000 new patients per year can be expected to have an ASD. Successful
 surgical repair of ASD has been performed for 50 years with continued improvement in
 technique and outcomes. King and Mills reported the first transcatheter closure of ASD in
 1976, but the delivery system was quite large and impractical, especially for younger
 patients. With time, improvements in design concepts and materials discoveries have led to
 improved results in transcatheter closure systems. Several devices are now available
 commercially for transcatheter ASD closure.
Inclusion Criteria:

 -  ASD less than or equal to 17 mm.

 Exclusion Criteria:

 -  Conditions that would confound treatment of ASD or complicate distinguishing onset of
 adverse events.

 -  Unable to accommodate device delivery catheter.