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ACTIVE NOT RECRUITING
NCT03309332
NA

AMPLATZER PFO Occluder Post Approval Study

Sponsor: Abbott Medical Devices

View on ClinicalTrials.gov

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

Interventions

DEVICE

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