N/A
Completed N=215
Long-term Safety Study of the GORE® HELEX® Septal Occluder
Septal Defect, Atrial
Source: ClinicalTrials.gov NCT00581308 ↗
Enrolled (actual)
215
Serious AEs
4.2%
Results posted
Feb 2012
Primary outcomePrimary: Efficacy — 180; 171; 9; 8 Participants
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Efficacy |
152; 143; 9; 9; 0; 58 | — |
| PRIMARY Safety |
10 | — |
Eligibility Criteria
Inclusion Criteria
- ASD less than or equal to 18 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 (NCT00581308). 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.