At a glance
ClinicalIndex Comparison RecordN/ACompleted· 436 enrolled
Drug / intervention
Device closure with AMPLATZER Duct Occluder +1 moredevice
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 Patent Ductus Arteriosus With the AMPLATZER Duct Occluder the AMPLATZER® Duct Occluder
In Brief
A clinical study evaluating Device closure with AMPLATZER Duct Occluder and Objective Performance Criteria for Patent Ductus Arteriosus (PDA). Completed, enrolled 436 participants across 24 sites.
Detailed Summary
AGA-004 - The objective of the study is to determine safety, effectiveness and clinical utility of the AMPLATZER Duct Occluder in patients with patent ductus arteriosus. AGA-007 - The objective of this study is to evaluate the long term safety and effectiveness issues that may not have have been adequately addressed during AGA-004.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPatent Ductus Arteriosus (PDA)
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
19992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartOct 1999
First PostedDec 2007
Primary CompletionApr 2008
Study CompletionFeb 2009
TodayJul 2026
First PostedDec 31, 2007
Enrollment StartOct 1, 1999
Primary CompletionApr 1, 2008
Study CompletionFeb 1, 2009
TodayJul 2, 2026
Enrollment to primary: 8.5 yearsPosted 18.5 years ago
Interventions
Device closure with AMPLATZER Duct Occluderdevice
Device closure with AMPLATZER Duct Occluder
Objective Performance Criteriaother
Compare results of device closure to objective performance criteria