Safety and Efficacy of the GORE® Septal Occluder to Treat Ostium Secundum Atrial Septal Defects

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.