Long-term Safety Study of the GORE® HELEX® Septal Occluder
Long-term Safety Study of the GORE® HELEX® Septal Occluder
The purpose of this study is to evaluate the long-term safety and efficacy of the GORE®
 HELEX® Septal Occluder in the treatment of ostium secundum atrial septal defects (ASDs).
The GORE® HELEX® Septal Occluder is an approved medical device indicated for the
 transcatheter closure of atrial septal defects (ASDs). The purpose of this study is to
 evaluate the long-term safety and efficacy of the GORE® HELEX® Septal Occluder in the
 treatment of ostium secundum atrial septal defects (ASDs). This is an FDA Condition of
 Approval Study. All subjects enrolled in this study will be followed for long-term safety and
 efficacy of the occluder device through 5 years.
Inclusion Criteria:

 -  ASD less than or equal to 18 mm.

 Exclusion Criteria:

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

 -  Unable to accommodate device delivery catheter.