Long-term Safety Study of the GORE® HELEX® Septal Occluder

GORE® HELEX® Septal Occluder Post-Approval Study

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.