CompletedNot Applicable

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

United States400 participantsStarted 2012-10

Plain-language summary

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.

Who can participate

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * ASD less than or equal to 17 mm. Exclusion Criteria: * Conditions that would confound treatment of ASD or complicate distinguishing onset of adverse events. * Unable to accommodate device delivery catheter.

What they're measuring

Number of Subjects With 6-Month Composite Clinical Success

Timeframe: 6 months

Trial details

NCT IDNCT01711983

SponsorW.L.Gore & Associates

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-11-26

Results submitted2020-06-29

View on ClinicalTrials.gov More Septal Defect, Atrial trials