At a glance
ClinicalIndex Comparison RecordN/ACompleted· 125 enrolled
Drug / intervention
GORE® CARDIOFORM ASD 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® CARDIOFORM ASD Occluder Clinical Study: A Study to Evaluate Safety and Efficacy in the Treatment of Transcatheter Closure of Ostium Secundum Atrial Septal Defects (ASDs) - The Gore ASSURED Clinical Study
In Brief
A clinical study evaluating GORE® CARDIOFORM ASD Occluder for Atrial Septal Defect. Completed, enrolled 125 participants across 22 sites.
Detailed Summary
Evaluate the safety and efficacy of the GORE® CARDIOFORM ASD Occluder in the percutaneous closure of ostium secundum atrial septal defects (ASDs)
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtrial Septal Defect
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedDec 2016
Enrollment StartMar 2017
Primary CompletionJul 2018
Study CompletionSep 2022
TodayJul 2026
First PostedDec 7, 2016
Enrollment StartMar 10, 2017
Primary CompletionJul 30, 2018
Study CompletionSep 29, 2022
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 9.6 years ago
Interventions
GORE® CARDIOFORM ASD Occluderdevice
Percutaneous Atrial Septal Defect Closure