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

Septal Defect, Atrial Clinical Trial

Official title:
GORE® HELEX® Septal Occluder Post-Approval Study

Status Completed

Clinical Trial 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).

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00581308
Study type	Interventional
Source	W.L.Gore & Associates
Contact
Status	Completed
Phase	N/A
Start date	August 2006
Completion date	October 2014

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT01711983` - Safety and Efficacy of the GORE® Septal Occluder to Treat Ostium Secundum Atrial Septal Defects	N/A
Enrolling by invitation	`NCT03373929` - Stitch Closure of PFO and Septal Repair	N/A
Withdrawn	`NCT04395027` - Iatrogenic Atrial Septal Defect Study (iASD)	Phase 3
Enrolling by invitation	`NCT05025475` - Stitch Closure of PFO and Septal Repair (STITCH)	N/A