At a glance
ClinicalIndex Comparison RecordN/ACompleted· 1,000 enrolled
Drug / intervention
AMPLATZER 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.
Closure of Atrial Septal Defects With the AMPLATZER Septal Occluder - Post Approval Study
In Brief
A clinical study evaluating AMPLATZER Septal Occluder for Atrial Septal Defect. Completed, enrolled 1,000 participants across 51 sites.
Detailed Summary
The purpose of this study is to prospectively evaluate the incidence of hemodynamic compromise and to obtain long-term survival data on patients with the AMPLATZER Septal Occluder
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtrial Septal Defect
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartAug 2007
First PostedApr 2008
Primary CompletionJun 2014
TodayJul 2026
First PostedApr 2, 2008
Enrollment StartAug 1, 2007
Primary CompletionJun 1, 2014
TodayJul 2, 2026
Enrollment to primary: 6.8 yearsPosted 18.3 years ago
Interventions
AMPLATZER Septal Occluderdevice
AMPLATZER Septal Occluder