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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
436
Device closure with AMPLATZER Duct Occluder
Compare results of device closure to objective performance criteria
University of Alabama
Birmingham, Alabama, United States
Reporting of Late Adverse Events Relating to the Device.
Time frame: Long term follow up for data captured at 5, 6 or 7 years post implant
Reporting of Late Efficacy Issues Regarding Patent Ductus Arteriosis (PDA) Closure
The number of participants with a residual shunt (efficacy)
Time frame: Long term follow up data captured at 5, 6 or 7 years post implant
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