Patent Ductus Arteriosus (PDA)NCT00583596

Closure Of Patent Ductus Arteriosus With the AMPLATZER Duct Occluder the AMPLATZER® Duct Occluder

A study testing Device closure with AMPLATZER Duct Occluder and Objective Performance Criteria in people with Patent Ductus Arteriosus (PDA), run by Abbott Medical Devices at 24 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 6 months to 18 years
Conditions the study is for: Patent Ductus Arteriosus (PDA)
What is being tested?: Device closure with AMPLATZER Duct Occluder and Objective Performance Criteria
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 436 participants
Where: 24 sitesUnited States
Study dates: Oct 1999to Feb 2009
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 months to 18 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Patients with a demonstrated patent ductus arteriosus
Body weight > 5 Kilograms

Who cannot join

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

Trial locations and contacts

24 sites in 1 country.

City, postcode or hospital

24 sites in 1 country

United States24 sites

University of Alabama
Birmingham, Alabama, 35294
New England Medical Center
Boston, Massachusetts, 02111
University of North Carolina
Chapel Hill, North Carolina, 27599
Medical University of South Carolina
Charleston, South Carolina, 29425
University of Chicago
Chicago, Illinois, 60637
University of Texas
Dallas, Texas, 75235
Children's Hospital
Denver, Colorado, 80218
Cook Children's Heart Center
Fort Worth, Texas, 76104
University of Florida
Gainesville, Florida, 32610
Indiana University School of Medicine
Indianapolis, Indiana, 46202
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53201
University of Minnesota
Minneapolis, Minnesota, 55455
Louisana State University Medical Center
New Orleans, Louisiana, 70112
Columbia University
New York, New York, 10032
Children's Hospital of the King's Daughters
Norfolk, Virginia, 30322
Children's Hospital UN/CU)
Omaha, Nebraska, 68114
Arnold Palmer Hospital
Orlando, Florida, 32806
Mayo Clinic
Rochester, Minnesota, 55905
Childrens Hospital
Rochester, New York, 14642
Children's Hospital
San Diego, California, 92123
University of Washington Medical Center
Seattle, Washington, 98195
Washington University Medical Center
St Louis, Missouri, 63110
Children's National Medical Center
Washington D.C., District of Columbia, 20010

Other trials in United States

About this study

Conditions: Patent Ductus Arteriosus (PDA)
Being tested: Device closure with AMPLATZER Duct Occluder, Objective Performance Criteria
Keywords: patent ductus arteriosus (PDA)
Medical subject headings: Ductus Arteriosus, Patent

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Device closure with AMPLATZER Duct OccluderDevice
Device closure with AMPLATZER Duct Occluder
Objective Performance CriteriaOther
Compare results of device closure to objective performance criteria

Study groups in NCT00583596
Study group	Role	What they receive
implant to close PDA	Experimental	Not described Receives: Device: Device closure with AMPLATZER Duct Occluder; Other: Objective Performance Criteria

What is being measured

The primary outcome is the main question the study is designed to answer.

Reporting of Late Adverse Events Relating to the Device.
Measured: 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)
Measured: Long term follow up data captured at 5, 6 or 7 years post implant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 1999Feb 2009

First posted31 Dec 2007 (estimated)
Study startOct 1999
Primary completionApr 2008
Study completionFeb 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Patent Ductus Arteriosus (PDA)Studies of the same condition, open and under way.
More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 436 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00583596
Sponsor's protocol ID: AGA-004
Other IDs: G980103
Status last verified: Jun 2023
First submitted: 20 Dec 2007
Last updated: 29 Jun 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Expanded access: Available

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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