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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ACTIVE_NOT_RECRUITING
NA
1214 participants
INTERVENTIONAL
2018-01-31
2030-02-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Device
Subjects implanted with the AMPLATZER™ PFO Occluder.
AMPLATZER™ PFO Occluder
Implantation of the AMPLATZER™ PFO Occluder in the PFO
Interventions
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AMPLATZER™ PFO Occluder
Implantation of the AMPLATZER™ PFO Occluder in the PFO
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
* Organ failure (kidney, liver or lung). Kidney failure: Poor urine output of less than 1 cc/kg/hr with elevated BUN levels (above the normal reference range for the laboratory at the investigational site). Liver failure: Liver enzymes outside the normal reference range for the laboratory at the investigational site: poor liver function as assessed by elevated PT (above the normal reference range for the laboratory at the investigational site) and low total protein and albumin (below the normal reference range for the laboratory at the investigational site). Lung failure: Respiratory failure is retention of carbon dioxide more than 60 mmHg, poor oxygenation with oxygen tension less than 40 mmHg in room air or the need for assisted ventilation.
* Uncontrolled hypertension defined as sustained elevated systemic blood pressure to more than 160/90 mmHg with medications
* Uncontrolled diabetes defined as continued elevated glucose levels in spite of administration of insulin/levels of more than 200 mg with presence of glucose in the urine
* Diagnosis of lacunar infarct probably due to intrinsic small vessel as qualifying stroke event Definition: Ischemic stroke in the distribution of a single, small deep penetrating vessel in a patient with any of the following: 1) a history of hypertension (except in the first week post stroke); 2) history of diabetes mellitus; 3) Age \>/= 50; or 4) MRI or CT shows leukoaraiosis greater than symmetric, well-defined periventricular caps or bands (European Task Force on Age-Related White Matter Changes rating scale score \> 0)
* Arterial dissection as cause of stroke
* Subjects who test positive with one of the following hypercoagulable states; Anticardiolipin Ab of the IgG or IgM (≥30), Lupus anticoagulant, B2-glycoprotein-1 antibodies (≥30) or persistently elevated homocysteine (\>20)
* Unable to take antiplatelet therapy
* Anatomy in which the AMPLATZERTM PFO Occluder device size required would interfere with intracardiac or intravascular structures such as valves or pulmonary veins
* Vasculature, through which access to the PFO is gained, is inadequate to accommodate the appropriate sheath size
* Malignancy or other illness where life expectancy is less than 2 years
* Subjects who will not be available for follow-up for the duration of the trial
* Inability to obtain Informed Consent from patient
* Index stroke of poor outcome (modified Rankin score greater than 3)
18 Years
60 Years
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Responsible Party
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Principal Investigators
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Barathi Sethuraman, PhD
Role: STUDY_DIRECTOR
Abbott
Locations
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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
Countries
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Other Identifiers
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SJM-CIP-10187
Identifier Type: -
Identifier Source: org_study_id