CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 215 enrolled
Drug / intervention
GORE® HELEX® Septal Occluderdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00581308
NCT00581308N/ACompleted
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GORE® HELEX® Septal Occluder Post-Approval Study

W.L.Gore & Associates·interventional·Posted Dec 27, 2007·Updated Feb 19, 2018

In Brief

A clinical study evaluating GORE® HELEX® Septal Occluder for Septal Defect, Atrial. Completed, enrolled 215 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSeptal Defect, Atrial
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 27, 2007
Enrollment StartAug 1, 2006
Primary CompletionOct 1, 2009
Study CompletionOct 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 18.5 years ago

Interventions

GORE® HELEX® Septal Occluderdevice

Percutaneous transcatheter closure of ostium secundum atrial septal defects (ASDs)