NCT00581308

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

GORE® HELEX® Septal Occluder Post-Approval Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 215 (actual)
• Sponsor: W.L.Gore & Associates · Industry
• Sex: All
• Age: —
• Healthy volunteers: Accepted

Summary

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).

Detailed description

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.

Conditions

• Septal Defect, Atrial

Interventions

Type	Name	Description
DEVICE	GORE® HELEX® Septal Occluder	Percutaneous transcatheter closure of ostium secundum atrial septal defects (ASDs)

Timeline

• Start date: 2006-08-01
• Primary completion: 2009-10-01
• Completion: 2014-10-01
• First posted: 2007-12-27
• Last updated: 2018-02-19
• Results posted: 2012-02-07

Locations

1 site across 1 country: United States