--- title: Closure Of Patent Ductus Arteriosus With the AMPLATZER Duct Occluder the AMPLATZER® Duct Occluder nct_id: NCT00583596 overall_status: COMPLETED phase: NA sponsor: Abbott Medical Devices study_type: INTERVENTIONAL primary_condition: Patent Ductus Arteriosus (PDA) countries: United States canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00583596.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00583596" ct_last_update_post_date: 2023-06-29 last_seen_at: "2026-05-12T06:59:41.685Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # Closure Of Patent Ductus Arteriosus With the AMPLATZER Duct Occluder the AMPLATZER® Duct Occluder **NCT ID:** [NCT00583596](https://clinicaltrials.gov/study/NCT00583596) ## Key Facts - **Status:** COMPLETED - **Phase:** NA - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 436 - **Lead Sponsor:** Abbott Medical Devices - **Conditions:** Patent Ductus Arteriosus (PDA) - **Start Date:** 1999-10 - **Completion Date:** 2009-02 - **CT.gov Last Update:** 2023-06-29 ## Brief 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 - **Minimum age:** 6 Months - **Maximum age:** 18 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` 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 ``` ## Arms - **implant to close PDA** (EXPERIMENTAL) ## Interventions - **Device closure with AMPLATZER Duct Occluder** (DEVICE) — Device closure with AMPLATZER Duct Occluder - **Objective Performance Criteria** (OTHER) — Compare results of device closure to objective performance criteria ## Primary Outcomes - **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** _(time frame: Long term follow up data captured at 5, 6 or 7 years post implant)_ — The number of participants with a residual shunt (efficacy) ## Locations (24) - University of Alabama, Birmingham, Alabama, United States - Children's Hospital, San Diego, California, United States - Children's Hospital, Denver, Colorado, United States - Children's National Medical Center, Washington D.C., District of Columbia, United States - University of Florida, Gainesville, Florida, United States - Arnold Palmer Hospital, Orlando, Florida, United States - University of Chicago, Chicago, Illinois, United States - Indiana University School of Medicine, Indianapolis, Indiana, United States - Louisana State University Medical Center, New Orleans, Louisiana, United States - New England Medical Center, Boston, Massachusetts, United States - University of Minnesota, Minneapolis, Minnesota, United States - Mayo Clinic, Rochester, Minnesota, United States - University of Mississippi Medical Center, Jackson, Mississippi, United States - Washington University Medical Center, St Louis, Missouri, United States - Children's Hospital UN/CU), Omaha, Nebraska, United States - Columbia University, New York, New York, United States - Childrens Hospital, Rochester, New York, United States - University of North Carolina, Chapel Hill, North Carolina, United States - Medical University of South Carolina, Charleston, South Carolina, United States - University of Texas, Dallas, Texas, United States - Cook Children's Heart Center, Fort Worth, Texas, United States - Children's Hospital of the King's Daughters, Norfolk, Virginia, United States - University of Washington Medical Center, Seattle, Washington, United States - Children's Hospital of Wisconsin, Milwaukee, Wisconsin, United States ## Recent Field Changes (last 30 days) - `status.completionDate` — added _(2026-05-12)_ - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.maxAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.university of alabama|birmingham|alabama|united states` — added _(2026-05-12)_ - `locations.children's hospital|san diego|california|united states` — added _(2026-05-12)_ - `locations.children's hospital|denver|colorado|united states` — added _(2026-05-12)_ - `locations.children's national medical center|washington d.c.|district of columbia|united states` — added _(2026-05-12)_ - `locations.university of florida|gainesville|florida|united states` — added _(2026-05-12)_ - `locations.arnold palmer hospital|orlando|florida|united states` — added _(2026-05-12)_ - `locations.university of chicago|chicago|illinois|united states` — added _(2026-05-12)_ - `locations.indiana university school of medicine|indianapolis|indiana|united states` — added _(2026-05-12)_ - `locations.louisana state university medical center|new orleans|louisiana|united states` — added _(2026-05-12)_ - `locations.new england medical center|boston|massachusetts|united states` — added _(2026-05-12)_ - `locations.university of minnesota|minneapolis|minnesota|united states` — added _(2026-05-12)_ - `locations.mayo clinic|rochester|minnesota|united states` — added _(2026-05-12)_ - `locations.university of mississippi medical center|jackson|mississippi|united states` — added _(2026-05-12)_ - `locations.washington university medical center|st louis|missouri|united states` — added _(2026-05-12)_ - `locations.children's hospital un/cu)|omaha|nebraska|united states` — added _(2026-05-12)_ - `locations.columbia university|new york|new york|united states` — added _(2026-05-12)_ - `locations.childrens hospital|rochester|new york|united states` — added _(2026-05-12)_ - `locations.university of north carolina|chapel hill|north carolina|united states` — added _(2026-05-12)_ - `locations.medical university of south carolina|charleston|south carolina|united states` — added _(2026-05-12)_ - `locations.university of texas|dallas|texas|united states` — added _(2026-05-12)_ - `locations.cook children's heart center|fort worth|texas|united states` — added _(2026-05-12)_ - `locations.children's hospital of the king's daughters|norfolk|virginia|united states` — added _(2026-05-12)_ - `locations.university of washington medical center|seattle|washington|united states` — added _(2026-05-12)_ - `locations.children's hospital of wisconsin|milwaukee|wisconsin|united states` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT00583596.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT00583596* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*