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

Patent Ductus Arteriosus (PDA) Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00583596
• Other study ID #: AGA-004
• Secondary ID: G980103
• Status: Completed
• Phase: N/A
• Start date: October 1999
• Est. completion date: February 2009

Study information

• Verified date: June 2023
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 during AGA-004.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 436
• Est. completion date: February 2009
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Ductus Arteriosus, Patent
• Patent Ductus Arteriosus (PDA)

Intervention

Device:
• Device closure with AMPLATZER Duct Occluder
Device closure with AMPLATZER Duct Occluder

Other:
• Objective Performance Criteria
Compare results of device closure to objective performance criteria

Locations

Country	Name	City	State
United States	University of Alabama	Birmingham	Alabama
United States	New England Medical Center	Boston	Massachusetts
United States	University of North Carolina	Chapel Hill	North Carolina
United States	Medical University of South Carolina	Charleston	South Carolina
United States	University of Chicago	Chicago	Illinois
United States	University of Texas	Dallas	Texas
United States	Children's Hospital	Denver	Colorado
United States	Cook Children's Heart Center	Fort Worth	Texas
United States	University of Florida	Gainesville	Florida
United States	Indiana University School of Medicine	Indianapolis	Indiana
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	Children's Hospital of Wisconsin	Milwaukee	Wisconsin
United States	University of Minnesota	Minneapolis	Minnesota
United States	Louisana State University Medical Center	New Orleans	Louisiana
United States	Columbia University	New York	New York
United States	Children's Hospital of the King's Daughters	Norfolk	Virginia
United States	Children's Hospital UN/CU)	Omaha	Nebraska
United States	Arnold Palmer Hospital	Orlando	Florida
United States	Childrens Hospital	Rochester	New York
United States	Mayo Clinic	Rochester	Minnesota
United States	Washington University Medical Center	Saint Louis	Missouri
United States	Children's Hospital	San Diego	California
United States	University of Washington Medical Center	Seattle	Washington
United States	Children's National Medical Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reporting of Late Adverse Events Relating to the Device.		Long term follow up for data captured at 5, 6 or 7 years post implant
Primary	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