Closure Of Patent Ductus Arteriosus With the AMPLATZER Duct Occluder the AMPLATZER® Duct Occluder
2 other identifiers
interventional
436
1 country
24
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 1999
Longer than P75 for not_applicable
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 1999
CompletedFirst Submitted
Initial submission to the registry
December 20, 2007
CompletedFirst Posted
Study publicly available on registry
December 31, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2009
CompletedResults Posted
Study results publicly available
July 18, 2014
CompletedJune 29, 2023
June 1, 2023
8.5 years
December 20, 2007
January 17, 2014
June 27, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Reporting of Late Adverse Events Relating to the Device.
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)
Long term follow up data captured at 5, 6 or 7 years post implant
Study Arms (1)
implant to close PDA
EXPERIMENTALInterventions
Device closure with AMPLATZER Duct Occluder
Compare results of device closure to objective performance criteria
Eligibility Criteria
You may qualify if:
- Patients with a demonstrated patent ductus arteriosus
- Body weight \> 5 Kilograms
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
University of Alabama
Birmingham, Alabama, 35294, United States
Children's Hospital
San Diego, California, 92123, United States
Children's Hospital
Denver, Colorado, 80218, United States
Children's National Medical Center
Washington D.C., District of Columbia, 20010, United States
University of Florida
Gainesville, Florida, 32610, United States
Arnold Palmer Hospital
Orlando, Florida, 32806, United States
University of Chicago
Chicago, Illinois, 60637, United States
Indiana University School of Medicine
Indianapolis, Indiana, 46202, United States
Louisana State University Medical Center
New Orleans, Louisiana, 70112, United States
New England Medical Center
Boston, Massachusetts, 02111, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Washington University Medical Center
St Louis, Missouri, 63110, United States
Children's Hospital UN/CU)
Omaha, Nebraska, 68114, United States
Columbia University
New York, New York, 10032, United States
Childrens Hospital
Rochester, New York, 14642, United States
University of North Carolina
Chapel Hill, North Carolina, 27599, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
University of Texas
Dallas, Texas, 75235, United States
Cook Children's Heart Center
Fort Worth, Texas, 76104, United States
Children's Hospital of the King's Daughters
Norfolk, Virginia, 30322, United States
University of Washington Medical Center
Seattle, Washington, 98195, United States
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53201, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jeffrey Mifek
- Organization
- St. Jude Medical Formally AGA Medical Corporation
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
December 20, 2007
First Posted
December 31, 2007
Study Start
October 1, 1999
Primary Completion
April 1, 2008
Study Completion
February 1, 2009
Last Updated
June 29, 2023
Results First Posted
July 18, 2014
Record last verified: 2023-06