OSB Lead-AMPLATZER PFO Occluder New Enrollment PAS
Status: Active_not_recruiting
Location: See all (88) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:
• • Subjects with a PFO who have had an ischemic stroke within the last 547 days
Locations
United States
Alabama
University of Alabama at Birmingham
Birmingham
Heart Center Research, LLC
Huntsville
Arkansas
UAMS Medical Center
Little Rock
Arizona
Chandler Regional Medical Center
Chandler
St. Joseph's Hospital and Medical Center
Phoenix
Scottsdale Healthcare Shea
Scottsdale
Pima Heart Physicians, PC
Tucson
California
Kaiser Permanente Los Angeles Medical Center
Los Angeles
Ronald Reagan UCLA Medical Center
Los Angeles
USC University Hospital
Los Angeles
Sutter Medical Center
Sacramento
San Diego Cardiac Center
San Diego
University of California at San Francisco
San Francisco
Stanford University Medical Center
Stanford
Los Robles Hospital and Medical Center
Thousand Oaks
Colorado
University of Colorado Hospital
Aurora
Memorial Hospital of Colorado Springs
Colorado Springs
Denver Heart
Denver
South Denver Cardiology Associates PC
Littleton
Washington, D.c.
MedStar Washington Hospital Center
Washington D.c.
Florida
Baptist Medical Center
Jacksonville
First Coast Cardiovascular Institute
Jacksonville
St. Vincent's Medical Center
Jacksonville
Orlando Health
Orlando
Cleveland Clinic Florida
Weston
Georgia
Augusta University
Augusta
Northeast Georgia Medical Center
Gainesville
WellStar Kennestone Hospital
Marietta
Illinois
Rush University Medical Center
Chicago
Prairie Education and Research Cooperative
Springfield
Kansas
HCA Midwest Division, Menorah Medical Center
Overland Park
Kentucky
University of Kentucky
Lexington
Baptist Hospital East
Louisville
Louisiana
Ochsner Medical Center
New Orleans
Massachusetts
Tufts Medical Center
Boston
Charlton Memorial Hospital
Fall River
Maryland
Johns Hopkins University Hospital
Baltimore
Michigan
McLaren Health Care Corporation
Auburn Hills
Children's Hospital of Michigan
Detroit
Henry Ford Hospital
Detroit
Sparrow Clinical Research Institute
Lansing
Minnesota
St. Mary's Hospital
Duluth
Minneapolis Heart Institute
Minneapolis
St. Cloud Hospital
Saint Cloud
Missouri
Mercy Hospital South
St Louis
Washington University School of Medicine
St Louis
Montana
Providence St. Patrick Hospital
Missoula
North Carolina
Novant Health Heart and Vascular Research
Charlotte
Moses H Cone Memorial Hospital
Greensboro
Forsyth Medical Center
Winston-salem
Nebraska
University of Nebraska Medical Center
Omaha
New Jersey
Newark Beth Israel Medical Center
Newark
New York
Mount Sinai Hospital
New York
New York Presbyterian Hospital/ Cornell University
New York
Stony Brook University Medical Center
Stony Brook
Ohio
Jewish Hospital
Cincinnati
TriHealth Bethesda North Hospital
Cincinnati
Mt Carmel East
Columbus
Ohio Health Research Institute
Columbus
Ohio State University
Columbus
Oregon
Kaiser Sunnyside Medical Center
Clackamas
Providence Heart and Vascular Institute
Portland
Pennsylvania
Geisinger Medical Center
Danville
Penn State Milton S Hershey Medical Center
Hershey
Allegheny General Hospital - ASRI
Pittsburgh
South Carolina
Lexington Medical Center
West Columbia
South Dakota
Sanford USD Medical Center
Sioux Falls
Tennessee
Erlanger Medical Center
Chattanooga
Tennova Healthcare - Turkey Creek Medical Center
Knoxville
Texas
Ascension Texas Cardiovascular Research
Austin
HCA Houston Healthcare Medical Center
Houston
University of Texas Health Science Center at Houston
Houston
Baylor Scott & White - The Heart Hospital Baylor Plano
Plano
Virginia
Sentara Norfolk General Hospital
Norfolk
Washington
Swedish Medical Center - Heart & Vascular
Seattle
University of Washington Medical Center
Seattle
Wisconsin
University of Wisconsin Hospital
Madison
Aurora Medical Group
Milwaukee
Other Locations
Canada
Foothills Medical Centre
Calgary
Institut de Cardiologie de Montreal (Montreal Heart Inst.)
Montreal
Toronto General Hospital
Toronto
Vancouver General Hospital
Vancouver
Germany
Deutsches Herzzentrum Berlin
Berlin
TUM Klinikum - Deutsches Herzzentrum München
München
Italy
Centro Cardiologico Monzino
Milan
Portugal
Santa Maria Hospital
Lisbon
Switzerland
Kantonsspital St.Gallen
Sankt Gallen
United Kingdom
St. Thomas Hospital
London
Time Frame
Start Date: 2018-01-31
Completion Date: 2030-02-05
Participants
Target number of participants: 1214
Treatments
Experimental: Device
Subjects implanted with the AMPLATZER™ PFO Occluder.
Authors
Santiago Garcia, Tomasz Stys, James Jenkins, Bassem Chehab, Jamil Aboulhosn, Oluseun Alli, Amar Patel, Michael Wahl, Milind Shah, Matthew Wiisanen, Srinivasa Potluri, Kurt Jacobson, Christopher Semder, Edward Coverstone, Pranav Loyalka, James Hermiller, Sameer Gafoor, Paul Mahoney, Spencer Palmer, Nabil Dib, Ramon Quesada, Amish Desai, Robert Leonardi, Tanvir Bajwa, Michael Cooper, Wilson Ginete, Ethan Korngold, David Roberts, Abhimanyu Uberoi, Megan Coylewright, Mark Kozak, David Lasorda, David Thaler, Jonathan Rapp, Mark Gajjar, Noah Jones, Ruby Satpathy, Osvaldo Laurido-Soto, David Rizik, John Gurley, Deepak Talreja, Mihir Kanitkar, David Lee, David L Tirschwell, Shikhar Agarwal, James Maddux, Matthew Stahlman, Ahmad Munir, Cihan Cevik, Nam Cho, Konstantinos Boudoulas, Bangalore Deepak, Raghava Gollapudi, Barry Love, VijayKumar Kasi, Ray V Matthews, Mustafa Ahmed, Hursh Naik, Vaqar Ali, Jacob Dutcher, Nilesh Goswami, Lee MacDonald, Zahid Amin, Geoffrey Bergman, James Blankenship, Somjot Brar, Vishva Dev, Samer Garas, Adam Saltzman, Samuel Turner, Jeffrey Delaney, David Wood, Clifford Kavinsky, Pranav Kansara, Gaurav Dhar, Vaikom Mahadevan, Richard Smalling, Lowell Satler, Christopher Allen, David Marks, Eric Horlick, Reda Ibrahim
Related Therapeutic Areas
Sponsors
Leads: Abbott Medical Devices