N/A
N=436
Closure Of Patent Ductus Arteriosus With the AMPLATZER Duct Occluder the AMPLATZER® Duct Occluder
Patent Ductus Arteriosus (PDA)
Bottom Line
View on ClinicalTrials.gov: NCT00583596 ↗Enrolled (actual)
436
Serious AEs
0.2%
Results posted
Jul 2014
Primary outcome: Primary: Reporting of Late Adverse Events Relating to the Device. — 9 participant
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Device closure with AMPLATZER Duct Occluder (Device); Objective Performance Criteria (Other)
- Age
- Pediatric, Adult · 0+ yrs
- Sex
- All
- Sponsor
- Abbott Medical Devices
- Primary completion
- Apr 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Reporting of Late Adverse Events Relating to the Device. |
9 | — |
| PRIMARY Reporting of Late Efficacy Issues Regarding Patent Ductus Arteriosis (PDA) Closure |
— | — |
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.
Eligibility Criteria
Inclusion Criteria
- Patients with a demonstrated patent ductus arteriosus
- Body weight > 5 Kilograms
Exclusion Criteria
- Pulmonary vascular resistance above 8 Woods units or a Rp/Rs >0.4.
- Additional cardiac or non-cardiac abnormality that can reasonably be expected to significantly affect the patient's health adversely in the next two years, i.e.: cancer, Eisenmenger's syndrome, other serious congenital heart disease.
- Pelvic vein or inferior vena cava thrombosis
- Sepsis (local/generalized) or any type of infection that cannot be successfully treated prior to device placement.
- History of repeated pulmonary infection
- Demonstrated intracardiac thrombi on echocardiography • Inability to obtain informed consent
Data sourced from ClinicalTrials.gov (NCT00583596). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.