AMPLATZER PFO Occluder Post Approval Study
PFO PAS
OSB Lead-AMPLATZER PFO Occluder New Enrollment PAS
1 other identifier
interventional
1,214
7 countries
88
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable stroke
Started Jan 2018
Longer than P75 for not_applicable stroke
88 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 10, 2017
CompletedFirst Posted
Study publicly available on registry
October 13, 2017
CompletedStudy Start
First participant enrolled
January 31, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 5, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 5, 2030
March 11, 2026
January 1, 2026
12 years
October 10, 2017
March 9, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Primary Effectiveness: 5 year rate of recurrent ischemic stroke
5 year rate of recurrent ischemic stroke
Through 5 years
Primary Safety: Device or procedure related serious adverse events
Device or procedure related serious adverse events through 30 days
Through 30 days post implant
Study Arms (1)
Device
EXPERIMENTALSubjects implanted with the AMPLATZER™ PFO Occluder.
Interventions
Eligibility Criteria
You may qualify if:
- Subjects with a PFO who have had an ischemic stroke within the last 547 days
You may not qualify if:
- Atherosclerosis or other arteriopathy of the intracranial and extracranial vessels associated with a ≥ 50% lumen diameter supplying the involved lesion
- Intra-cardiac thrombus or tumor
- Documented evidence of venous thrombus in the vessels through which access to the PFO is gained
- Acute or recent (within 6 months prior to consent) myocardial infarction or unstable angina
- Left ventricular aneurysm or akinesis
- Mitral valve stenosis or severe mitral regurgitation requiring intervention irrespective of etiology
- Aortic valve stenosis (mean gradient \>40 mmHg) or severe aortic valve regurgitation
- Mitral or aortic valve vegetation or prosthesis
- Aortic arch plaques protruding greater than 4mm into the aortic lumen
- Left ventricular dilated cardiomyopathy with depressed left ventricular ejection fraction (LVEF less than 35%)
- Subjects with other source of right to left shunts, including an atrial septal defect and/or fenestrated septum
- Chronic, persistent, or paroxysmal atrial fibrillation or atrial flutter
- Pregnancy at the time of implant
- Age less than 18 years or greater than 60 years at time of consent
- Active endocarditis or other untreated infections
- +13 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (88)
University of Alabama at Birmingham
Birmingham, Alabama, 35249, United States
Heart Center Research, LLC
Huntsville, Alabama, 35801, United States
Chandler Regional Medical Center
Chandler, Arizona, 85224, United States
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013, United States
Scottsdale Healthcare Shea
Scottsdale, Arizona, 85260, United States
Pima Heart Physicians, PC
Tucson, Arizona, 85712, United States
UAMS Medical Center
Little Rock, Arkansas, 72205, United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 90027, United States
USC University Hospital
Los Angeles, California, 90033, United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095, United States
Sutter Medical Center
Sacramento, California, 95816, United States
San Diego Cardiac Center
San Diego, California, 92123, United States
University of California at San Francisco
San Francisco, California, 94143, United States
Stanford University Medical Center
Stanford, California, 94305, United States
Los Robles Hospital and Medical Center
Thousand Oaks, California, 91360, United States
University of Colorado Hospital
Aurora, Colorado, 80045, United States
Memorial Hospital of Colorado Springs
Colorado Springs, Colorado, 80909, United States
Denver Heart
Denver, Colorado, 80031, United States
South Denver Cardiology Associates PC
Littleton, Colorado, 80120, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
St. Vincent's Medical Center
Jacksonville, Florida, 32204, United States
Baptist Medical Center
Jacksonville, Florida, 32207, United States
First Coast Cardiovascular Institute
Jacksonville, Florida, 32256, United States
Orlando Health
Orlando, Florida, 32806, United States
Cleveland Clinic Florida
Weston, Florida, 33331, United States
Augusta University
Augusta, Georgia, 30912, United States
Northeast Georgia Medical Center
Gainesville, Georgia, 30501, United States
WellStar Kennestone Hospital
Marietta, Georgia, 98502, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Prairie Education and Research Cooperative
Springfield, Illinois, 63146, United States
HCA Midwest Division, Menorah Medical Center
Overland Park, Kansas, 66209, United States
University of Kentucky
Lexington, Kentucky, 40536, United States
Baptist Hospital East
Louisville, Kentucky, 40515, United States
Ochsner Medical Center
New Orleans, Louisiana, 70448, United States
Johns Hopkins University Hospital
Baltimore, Maryland, 21287, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Charlton Memorial Hospital
Fall River, Massachusetts, 02720, United States
McLaren Health Care Corporation
Auburn Hills, Michigan, 48326, United States
Henry Ford Hospital
Detroit, Michigan, 48084, United States
Children's Hospital of Michigan
Detroit, Michigan, 48201, United States
Sparrow Clinical Research Institute
Lansing, Michigan, 48912, United States
St. Mary's Hospital
Duluth, Minnesota, 55805, United States
Minneapolis Heart Institute
Minneapolis, Minnesota, 55407, United States
St. Cloud Hospital
Saint Cloud, Minnesota, 56303, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Mercy Hospital South
St Louis, Missouri, 63128, United States
Providence St. Patrick Hospital
Missoula, Montana, 59802, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Newark Beth Israel Medical Center
Newark, New Jersey, 07112, United States
Mount Sinai Hospital
New York, New York, 10019, United States
New York Presbyterian Hospital/ Cornell University
New York, New York, 10021, United States
Stony Brook University Medical Center
Stony Brook, New York, 11790, United States
Novant Health Heart and Vascular Research
Charlotte, North Carolina, 28204, United States
Moses H Cone Memorial Hospital
Greensboro, North Carolina, 27358, United States
Forsyth Medical Center
Winston-Salem, North Carolina, 27358, United States
Jewish Hospital
Cincinnati, Ohio, 45236, United States
TriHealth Bethesda North Hospital
Cincinnati, Ohio, 45242, United States
Ohio Health Research Institute
Columbus, Ohio, 43210, United States
Ohio State University
Columbus, Ohio, 43210, United States
Mt Carmel East
Columbus, Ohio, 43213, United States
Kaiser Sunnyside Medical Center
Clackamas, Oregon, 97015, United States
Providence Heart and Vascular Institute
Portland, Oregon, 97225, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822, United States
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Allegheny General Hospital - ASRI
Pittsburgh, Pennsylvania, 15212, United States
Lexington Medical Center
West Columbia, South Carolina, 29169, United States
Sanford USD Medical Center
Sioux Falls, South Dakota, 57117, United States
Erlanger Medical Center
Chattanooga, Tennessee, 37922, United States
Tennova Healthcare - Turkey Creek Medical Center
Knoxville, Tennessee, 37920, United States
Ascension Texas Cardiovascular Research
Austin, Texas, 78705, United States
HCA Houston Healthcare Medical Center
Houston, Texas, 77004, United States
University of Texas Health Science Center at Houston
Houston, Texas, 77074, United States
Baylor Scott & White - The Heart Hospital Baylor Plano
Plano, Texas, 75093, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, 23112, United States
Swedish Medical Center - Heart & Vascular
Seattle, Washington, 98122, United States
University of Washington Medical Center
Seattle, Washington, 98195, United States
University of Wisconsin Hospital
Madison, Wisconsin, 53792, United States
Aurora Medical Group
Milwaukee, Wisconsin, 53215, United States
Foothills Medical Centre
Calgary, Alberta, T2N 2T9, Canada
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9, Canada
Toronto General Hospital
Toronto, Ontario, M5G 2C4, Canada
Institut de Cardiologie de Montreal (Montreal Heart Inst.)
Montreal, Quebec, H1T 1C8, Canada
TUM Klinikum - Deutsches Herzzentrum München
München, Bavaria, 80636, Germany
Deutsches Herzzentrum Berlin
Berlin, State of Berlin, 13353, Germany
Centro Cardiologico Monzino
Milan, Lombard, Italy
Santa Maria Hospital
Lisbon, Lisbon District, 1649-035, Portugal
Kantonsspital St.Gallen
Sankt Gallen, Stgalln, 9007, Switzerland
St. Thomas Hospital
London, London, SE1 7EH, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Barathi Sethuraman, PhD
Abbott
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 10, 2017
First Posted
October 13, 2017
Study Start
January 31, 2018
Primary Completion (Estimated)
February 5, 2030
Study Completion (Estimated)
February 5, 2030
Last Updated
March 11, 2026
Record last verified: 2026-01