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

Primary Purpose

Patent Ductus Arteriosus (PDA)

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Device closure with AMPLATZER Duct Occluder
Objective Performance Criteria
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patent Ductus Arteriosus (PDA) focused on measuring patent ductus arteriosus (PDA)

Eligibility Criteria

6 Months - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama
  • Children's Hospital
  • Children's Hospital
  • Children's National Medical Center
  • University of Florida
  • Arnold Palmer Hospital
  • University of Chicago
  • Indiana University School of Medicine
  • Louisana State University Medical Center
  • New England Medical Center
  • University of Minnesota
  • Mayo Clinic
  • University of Mississippi Medical Center
  • Washington University Medical Center
  • Children's Hospital UN/CU)
  • Columbia University
  • Childrens Hospital
  • University of North Carolina
  • Medical University of South Carolina
  • University of Texas
  • Cook Children's Heart Center
  • Children's Hospital of the King's Daughters
  • University of Washington Medical Center
  • Children's Hospital of Wisconsin

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

implant to close PDA

Arm Description

Outcomes

Primary Outcome Measures

Reporting of Late Adverse Events Relating to the Device.
Reporting of Late Efficacy Issues Regarding Patent Ductus Arteriosis (PDA) Closure
The number of participants with a residual shunt (efficacy)

Secondary Outcome Measures

Full Information

First Posted
December 20, 2007
Last Updated
June 27, 2023
Sponsor
Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT00583596
Brief Title
Closure Of Patent Ductus Arteriosus With the AMPLATZER Duct Occluder the AMPLATZER® Duct Occluder
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
October 1999 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
February 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patent Ductus Arteriosus (PDA)
Keywords
patent ductus arteriosus (PDA)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
436 (Actual)

8. Arms, Groups, and Interventions

Arm Title
implant to close PDA
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Device closure with AMPLATZER Duct Occluder
Intervention Description
Device closure with AMPLATZER Duct Occluder
Intervention Type
Other
Intervention Name(s)
Objective Performance Criteria
Intervention Description
Compare results of device closure to objective performance criteria
Primary Outcome Measure Information:
Title
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
Title
Reporting of Late Efficacy Issues Regarding Patent Ductus Arteriosis (PDA) Closure
Description
The number of participants with a residual shunt (efficacy)
Time Frame
Long term follow up data captured at 5, 6 or 7 years post implant

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
University of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Children's Hospital
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Children's Hospital
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Children's National Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Arnold Palmer Hospital
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Indiana University School of Medicine
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Louisana State University Medical Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
New England Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Washington University Medical Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Children's Hospital UN/CU)
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Childrens Hospital
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
University of Texas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Cook Children's Heart Center
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Children's Hospital of the King's Daughters
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
30322
Country
United States
Facility Name
University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
Children's Hospital of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53201
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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