Clinical trial NCT00583596: Closure Of Patent Ductus Arteriosus With the AMPLATZER Duct Occluder the AMPLATZER® Duct Occluder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patent Ductus Arteriosus (PDA)
Keywords: patent ductus arteriosus (PDA)
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2007-12-31
Enrollment: 436
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Reporting of Late Adverse Events Relating to the Device.
timeFrame: Long term follow up for data captured at 5, 6 or 7 years post implant
measure: Reporting of Late Efficacy Issues Regarding Patent Ductus Arteriosis (PDA) Closure
timeFrame: Long term follow up data captured at 5, 6 or 7 years post implant
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
city: San Diego
country: United States
facility: Children's Hospital
state: California
city: Denver
country: United States
facility: Children's Hospital
state: Colorado
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Orlando
country: United States
facility: Arnold Palmer Hospital
state: Florida
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University School of Medicine
state: Indiana
city: New Orleans
country: United States
facility: Louisana State University Medical Center
state: Louisiana
city: Boston
country: United States
facility: New England Medical Center
state: Massachusetts
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Saint Louis
country: United States
facility: Washington University Medical Center
state: Missouri
city: Omaha
country: United States
facility: Children's Hospital UN/CU)
state: Nebraska
city: New York
country: United States
facility: Columbia University
state: New York
city: Rochester
country: United States
facility: Childrens Hospital
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Dallas
country: United States
facility: University of Texas
state: Texas
city: Fort Worth
country: United States
facility: Cook Children's Heart Center
state: Texas
city: Norfolk
country: United States
facility: Children's Hospital of the King's Daughters
state: Virginia
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
city: Milwaukee
country: United States
facility: Children's Hospital of Wisconsin
state: Wisconsin
Study officials:
References: