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AMPLATZER PFO Occluder Post Approval Study
Sponsor: Abbott Medical Devices
Summary
The purpose of this single arm, multi-center study is to confirm the safety and effectiveness of the AMPLATZER™ PFO Occluder in the post Approval Setting.
Official title: OSB Lead-AMPLATZER PFO Occluder New Enrollment PAS
Key Details
Gender
All
Age Range
18 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
1214
Start Date
2018-01-31
Completion Date
2030-02-05
Last Updated
2026-03-11
Healthy Volunteers
No
Conditions
Interventions
AMPLATZER™ PFO Occluder
Implantation of the AMPLATZER™ PFO Occluder in the PFO
Locations (88)
University of Alabama at Birmingham
Birmingham, Alabama, United States
Heart Center Research, LLC
Huntsville, Alabama, United States
Chandler Regional Medical Center
Chandler, Arizona, United States
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States
Scottsdale Healthcare Shea
Scottsdale, Arizona, United States
Pima Heart Physicians, PC
Tucson, Arizona, United States
UAMS Medical Center
Little Rock, Arkansas, United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States
USC University Hospital
Los Angeles, California, United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States
Sutter Medical Center
Sacramento, California, United States
San Diego Cardiac Center
San Diego, California, United States
University of California at San Francisco
San Francisco, California, United States
Stanford University Medical Center
Stanford, California, United States
Los Robles Hospital and Medical Center
Thousand Oaks, California, United States
University of Colorado Hospital
Aurora, Colorado, United States
Memorial Hospital of Colorado Springs
Colorado Springs, Colorado, United States
Denver Heart
Denver, Colorado, United States
South Denver Cardiology Associates PC
Littleton, Colorado, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
St. Vincent's Medical Center
Jacksonville, Florida, United States
Baptist Medical Center
Jacksonville, Florida, United States
First Coast Cardiovascular Institute
Jacksonville, Florida, United States
Orlando Health
Orlando, Florida, United States
Cleveland Clinic Florida
Weston, Florida, United States
Augusta University
Augusta, Georgia, United States
Northeast Georgia Medical Center
Gainesville, Georgia, United States
WellStar Kennestone Hospital
Marietta, Georgia, United States
Rush University Medical Center
Chicago, Illinois, United States
Prairie Education and Research Cooperative
Springfield, Illinois, United States
HCA Midwest Division, Menorah Medical Center
Overland Park, Kansas, United States
University of Kentucky
Lexington, Kentucky, United States
Baptist Hospital East
Louisville, Kentucky, United States
Ochsner Medical Center
New Orleans, Louisiana, United States
Johns Hopkins University Hospital
Baltimore, Maryland, United States
Tufts Medical Center
Boston, Massachusetts, United States
Charlton Memorial Hospital
Fall River, Massachusetts, United States
McLaren Health Care Corporation
Auburn Hills, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
Children's Hospital of Michigan
Detroit, Michigan, United States
Sparrow Clinical Research Institute
Lansing, Michigan, United States
St. Mary's Hospital
Duluth, Minnesota, United States
Minneapolis Heart Institute
Minneapolis, Minnesota, United States
St. Cloud Hospital
Saint Cloud, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
Mercy Hospital South
St Louis, Missouri, United States
Providence St. Patrick Hospital
Missoula, Montana, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Newark Beth Israel Medical Center
Newark, New Jersey, United States
Mount Sinai Hospital
New York, New York, United States
New York Presbyterian Hospital/ Cornell University
New York, New York, United States
Stony Brook University Medical Center
Stony Brook, New York, United States
Novant Health Heart and Vascular Research
Charlotte, North Carolina, United States
Moses H Cone Memorial Hospital
Greensboro, North Carolina, United States
Forsyth Medical Center
Winston-Salem, North Carolina, United States
Jewish Hospital
Cincinnati, Ohio, United States
TriHealth Bethesda North Hospital
Cincinnati, Ohio, United States
Ohio Health Research Institute
Columbus, Ohio, United States
Ohio State University
Columbus, Ohio, United States
Mt Carmel East
Columbus, Ohio, United States
Kaiser Sunnyside Medical Center
Clackamas, Oregon, United States
Providence Heart and Vascular Institute
Portland, Oregon, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, United States
Allegheny General Hospital - ASRI
Pittsburgh, Pennsylvania, United States
Lexington Medical Center
West Columbia, South Carolina, United States
Sanford USD Medical Center
Sioux Falls, South Dakota, United States
Erlanger Medical Center
Chattanooga, Tennessee, United States
Tennova Healthcare - Turkey Creek Medical Center
Knoxville, Tennessee, United States
Ascension Texas Cardiovascular Research
Austin, Texas, United States
HCA Houston Healthcare Medical Center
Houston, Texas, United States
University of Texas Health Science Center at Houston
Houston, Texas, United States
Baylor Scott & White - The Heart Hospital Baylor Plano
Plano, Texas, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
Swedish Medical Center - Heart & Vascular
Seattle, Washington, United States
University of Washington Medical Center
Seattle, Washington, United States
University of Wisconsin Hospital
Madison, Wisconsin, United States
Aurora Medical Group
Milwaukee, Wisconsin, United States
Foothills Medical Centre
Calgary, Alberta, Canada
Vancouver General Hospital
Vancouver, British Columbia, Canada
Toronto General Hospital
Toronto, Ontario, Canada
Institut de Cardiologie de Montreal (Montreal Heart Inst.)
Montreal, Quebec, Canada
TUM Klinikum - Deutsches Herzzentrum München
München, Bavaria, Germany
Deutsches Herzzentrum Berlin
Berlin, State of Berlin, Germany
Centro Cardiologico Monzino
Milan, Lombard, Italy
Santa Maria Hospital
Lisbon, Lisbon District, Portugal
Kantonsspital St.Gallen
Sankt Gallen, Stgalln, Switzerland
St. Thomas Hospital
London, London, United Kingdom