N/A
Completed N=400
Safety and Efficacy of the GORE® Septal Occluder to Treat Ostium Secundum Atrial Septal Defects
Septal Defect, Atrial
Source: ClinicalTrials.gov NCT01711983 ↗
Enrolled (actual)
400
Serious AEs
7.0%
Results posted
Aug 2020
Primary outcomePrimary: Number of Subjects With 6-Month Composite Clinical Success — 332 Participants — p=<0.0001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With 6-Month Composite Clinical Success |
332 | <0.0001 sig |
| SECONDARY Number of Subjects With Technical Success |
374 | — |
| SECONDARY Number of Subjects With Procedure Success |
364 | — |
| SECONDARY Number of Subjects With 30-day SAE |
7 | — |
| SECONDARY Number of Subjects With 6-Month Closure Success |
338 | — |
| SECONDARY Number of Subjects With 12-Month Closure Success |
337 | — |
| SECONDARY Number of Subjects With 36-Month Closure Success |
277 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01711983). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.