Safety and Efficacy of the GORE® Septal Occluder to Treat Ostium Secundum Atrial Septal Defects

Completed · Not applicable

Conditions studied: Septal Defect, Atrial

In brief

The primary objective of the GORE® Septal Occluder Study is to evaluate the safety and efficacy of the occluder device in the treatment of transcatheter closure of ostium secundum atrial septal defects (ASDs). The data obtained in this study will evaluate this next generation device as compared to outcomes of prior studies conducted with the GORE® HELEX® Septal Occluder.

Key facts

Study ID

NCT01711983

Run by

W.L.Gore & Associates

People needed

400

Starts

2012-10-01

Expected to finish

2018-11-26

Last updated by the study team

2020-08-21

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ASD less than or equal to 17 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

• University of Virginia, Children's Hospital Heart Center — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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