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NCT00581308 · ClinicalTrials.gov registry record · NA
Long-term Safety Study of the GORE® HELEX® Septal Occluder
A NA study, sponsored by W.L.Gore & Associates.
- Completed
- Registry status
- NA
- Development phase
- 215
- Enrollment target
NCT00581308: Completed NA study, sponsored by W.L.Gore & Associates.
NCT00581308 is a NA study that has completed, run by W.L.Gore & Associates. The registered enrollment target is 215 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00581308, a NA study, has completed, sponsored by W.L.Gore & Associates.
- COMPLETED
- Registry status
- NA
- Development phase
- 215 participants
- Enrollment target
Study 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).
Primary Outcome
A calculation of the proportion of subjects with clinically successful defect closure as determined by the site at 1, 3, and 5 years postprocedure. Clinical Success is a composite measure of safety and efficacy evaluated at the 12-, 36-, and 60-month post-procedure evaluations and is defined as absence of: * Any major device/procedure adverse event * Repeat procedure to the target ASD. Repeat procedures were considered major adverse events and are included in the major adverse event group. * Cl
Interventions
- DEVICE GORE® HELEX® Septal Occluder
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 215 participants |
| Start Date | 2006-08 |
| Est. Completion | 2014-10 |
| Phase | NA |
What the finished NCT00581308 record still lists
NCT00581308 is an interventional study that assigns participants to a tested intervention. The registered 215 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 1 intervention - of which GORE® HELEX® Septal Occluder is the first listed.
NCT00581308 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00581308 about?
NCT00581308 is a clinical study titled "Long-term Safety Study of the GORE® HELEX® Septal Occluder". 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).
What is the current status of trial NCT00581308?
This trial is currently completed. It is a NA study. The enrollment target is 215 participants. The study started on 2006-08. Estimated completion is 2014-10.
What interventions are being tested in trial NCT00581308?
The interventions under investigation include: GORE® HELEX® Septal Occluder (DEVICE).
Who is sponsoring clinical trial NCT00581308?
This trial is sponsored by W.L.Gore & Associates, which has 53 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00581308's enrollment target sits among peer trials
215 487th of 2000 higher than 1,514 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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