ADVANCE ASO AMPLATZER™ Atrial Septal Occluder Post Market Surveillance Study
NCT ID: NCT02353351
Last Updated: 2019-02-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
602 participants
OBSERVATIONAL
2015-01-19
2017-02-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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atrial septal occluder
Single arm atrial septal defect closure with the AMPLATZER Septal Occluder
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patient is willing and able to complete the follow-up requirements of this study
3. Patient signs the informed consent (or a legal representative signs the informed consent.)
Exclusion Criteria
2. Patient is known to have sepsis within 1 month prior to implantation, or any systemic infection that cannot be successfully treated prior to device placement
3. Patient is known to have a bleeding disorder, untreated ulcer, or any other contraindications to aspirin therapy (unless another anti-platelet agent can be administered for 6 months)
4. Patient is known to have a demonstrated intracardiac thrombus on echocardiography
5. Patient whose size (such as, too small for transesophageal echocardiography probe, catheter size) or condition (active infection, etc.) would cause the patient to be a poor candidate for cardiac catheterization
6. Patient has margins of defect that are less than 5 mm to the coronary sinus, AV valves or right upper lobe pulmonary vein
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Responsible Party
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Principal Investigators
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Ashish Oza
Role: STUDY_DIRECTOR
Abbott Medical Devices
Locations
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University of Alabama
Birmingham, Alabama, United States
University of Arizona
Tucson, Arizona, United States
University of Arkansas
Little Rock, Arkansas, United States
Children's Hospital Los Angeles
Los Angeles, California, United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States
University of Southern California
Los Angeles, California, United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States
Valley Children's Hospital
Madera, California, United States
Stanford University Medical Center
Palo Alto, California, United States
Huntington Memorial Hospital
Pasadena, California, United States
Rady Children's Hospital
San Diego, California, United States
Yale New Haven Hospital
New Haven, Connecticut, United States
Nemours/Alfred I. duPont Hospital for Children
Wilmington, Delaware, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
Clearwater Cardiovascular Consultants
Clearwater, Florida, United States
Baptist Medical Center
Jacksonville, Florida, United States
Florida Hospital Orlando
Orlando, Florida, United States
Arnold Palmer Hospital for Children
Orlando, Florida, United States
All Children's Hospital
St. Petersburg, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, United States
Riley Hospital for Children
Indianapolis, Indiana, United States
Iowa Heart Center / Mercy Medical Center
West Des Moines, Iowa, United States
Children's Hospital
New Orleans, Louisiana, United States
University of Maryland
Baltimore, Maryland, United States
Boston Children's Hospital
Boston, Massachusetts, United States
Children's Hospital of Michigan
Detroit, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
Children's Hospitals and Clinics of Minnesota
Minneapolis, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
St. Louis Children's Hospital
St Louis, Missouri, United States
Sunrise Hospital
Las Vegas, Nevada, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
Albany Medical College
Albany, New York, United States
Cohen Children's Medical Center
New Hyde Park, New York, United States
New York Presbyterian/Cornell
New York, New York, United States
Mount Sinai Hospital
New York, New York, United States
Children's Hospital of New York - Presbyterian
New York, New York, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Duke University Hospital
Durham, North Carolina, United States
East Carolina University
Greenville, North Carolina, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
The Ohio State University
Columbus, Ohio, United States
University of Oklahoma
Oklahoma City, Oklahoma, United States
Holy Spirit Hospital
Camp Hill, Pennsylvania, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Pinnacle Health
Harrisburg, Pennsylvania, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
University of Pennslyvania
Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
North Austin Medical Center
Austin, Texas, United States
Driscoll Children's Hospital
Corpus Christi, Texas, United States
Houston Methodist DeBakey Heart and Vascular Center
Houston, Texas, United States
Texas Children's Hospital / Baylor College of Medicine
Houston, Texas, United States
The University of Texas Health Science Center at Houston/Memorial Hermann Hospital
Houston, Texas, United States
Primary Children's Hospital
Salt Lake City, Utah, United States
University of Virginia
Charlottesville, Virginia, United States
Inova Fairfax Hospital
Falls Church, Virginia, United States
Seattle Children's Hospital
Seattle, Washington, United States
University of Washington
Seattle, Washington, United States
Providence Medical Research Group
Spokane, Washington, United States
University of Wisconsin
Madison, Wisconsin, United States
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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PS130046
Identifier Type: -
Identifier Source: org_study_id
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