Study Results
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View full resultsBasic Information
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COMPLETED
NA
192 participants
INTERVENTIONAL
2008-08-31
2016-10-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Device
AMPLATZER Duct Occluder II
AMPLATZER Duct Occluder II
Interventions
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AMPLATZER Duct Occluder II
AMPLATZER Duct Occluder II
Eligibility Criteria
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Inclusion Criteria
* Subject must have a PDA \< 5.5mm in diameter by angiography
* Subject must have a PDA \< 12mm in length by angiography
* Subject must have a PDA \> 3mm in length by angiography
* Subject/legally authorized representative must give consent to participate in the clinical study
* Subject/legally authorized representative must consent to follow-up for the duration of the clinical study
Exclusion Criteria
* Subject must not be \< 6 months of age
* Subject must not be ≥ 18 years of age
* Subject must not have a descending aorta \< 10mm in diameter
* Subject must not have a right to left shunt through the patent ductus arteriosus
* Subject must not have PVR above 8 Woods units or a Rp/Rs \>0.4
* Subject must not have intracardiac thrombus
* Subject must not have additional cardiac anomalies requiring surgical or interventional correction
* Subject must not have history of more than two lower respiratory infections within the last year (i.e., pneumonia)
* Subject must not have active infection requiring treatment at the time of implant
* Subject must not have contraindication to anticoagulation treatment
* Female subjects of child bearing age must not be pregnant or desire to become pregnant within six months post implant\*
* Subject must not be participating in another study for an investigational drug and/or device that may clinically interfere with this study's endpoints
* If the subject desires to become pregnant after six months post-implant, further restriction is at the discretion of their physician.
6 Months
18 Years
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Responsible Party
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Locations
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Children's Hospital and Health Center
San Diego, California, United States
University of California San Francisco Hospital
San Francisco, California, United States
The Children's Hospital - Denver
Aurora, Colorado, United States
Alfred I. DuPont Hospital for Children -Nemours Cardiac Center
Wilmington, Delaware, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
Memorial Regional Hospital (Joe DiMaggio Children's Hospital)
Hollywood, Florida, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, United States
Riley Hospital for Children
Indianapolis, Indiana, United States
Children's Hospital Boston
Boston, Massachusetts, United States
University of Minnesota
Minneapolis, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Washington University School of Medicine
St Louis, Missouri, United States
Mount Sinai School of Medicine
New York, New York, United States
The Children's Hospital Montefiore
The Bronx, New York, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
The Children's Hospital at Cleveland Clinic
Cleveland, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Vanderbilt Children's Hospital
Nashville, Tennessee, United States
University of Texas SW Medical Center
Dallas, Texas, United States
Texas Children's Hospital
Houston, Texas, United States
Primary Children's Medical Center
Salt Lake City, Utah, United States
Children's Hospital and Regional Medical Center
Seattle, Washington, United States
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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CL00233
Identifier Type: -
Identifier Source: org_study_id
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