At a glance
ClinicalIndex Comparison RecordN/ACompleted· 400 enrolled
Drug / intervention
GORE® CARDIOFORM 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.
GORE® Septal Occluder Clinical Study: A Study to Evaluate Safety and Efficacy in the Treatment of Transcatheter Closure of Ostium Secundum Atrial Septal Defects (ASDs)
In Brief
A clinical study evaluating GORE® CARDIOFORM Septal Occluder for Septal Defect, Atrial. Completed, enrolled 400 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSeptal Defect, Atrial
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartOct 2012
First PostedOct 2012
Primary CompletionNov 2018
TodayJul 2026
First PostedOct 23, 2012
Enrollment StartOct 1, 2012
Primary CompletionNov 26, 2018
TodayJul 2, 2026
Enrollment to primary: 6.2 yearsPosted 13.7 years ago
Interventions
GORE® CARDIOFORM Septal Occluderdevice
Percutaneous Atrial Septal Defect Closure