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

Completed · Not applicable

Conditions studied: Septal Defect, Atrial

In brief

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).

Key facts

Study ID

NCT00581308

Run by

W.L.Gore & Associates

People needed

215

Starts

2006-08-01

Expected to finish

2014-10-01

Last updated by the study team

2018-02-19

Who can join

Age: any. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• ASD less than or equal to 18 mm.

You may not qualify if…

• Conditions that would confound treatment of ASD or complicate distinguishing onset of adverse events.
• Unable to accommodate device delivery catheter.

Where it is running

• Cleveland Clinic Foundation — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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