AMPLATZER PFO Occluder Post Approval Study
- Conditions
- StrokePatent Foramen Ovale
- Interventions
- Device: AMPLATZER™ PFO Occluder
- Registration Number
- NCT03309332
- Lead Sponsor
- Abbott Medical Devices
- 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.
- Detailed Description
A maximum of 1214 adult subjects will be enrolled at up to 100 centers in the U.S. and Canada. Subjects will have follow-up at 1 month, 6 months, 12 months and annually thereafter through 5 years post implant.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1214
• Subjects with a PFO who have had an ischemic stroke within the last 547 days
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Device AMPLATZER™ PFO Occluder Subjects implanted with the AMPLATZER™ PFO Occluder.
- Primary Outcome Measures
Name Time Method Primary Safety: Device or procedure related serious adverse events Through 30 days post implant Device or procedure related serious adverse events through 30 days
Primary Effectiveness: 5 year rate of recurrent ischemic stroke Through 5 years 5 year rate of recurrent ischemic stroke
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (89)
Chandler Regional Medical Center
🇺🇸Chandler, Arizona, 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
Washington Hospital Center
🇺🇸Washington, 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
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
University of Massachusetts Medical Center
🇺🇸Worcester, 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
Mercy Hospital South
🇺🇸Saint Louis, Missouri, United States
St. Patrick Hospital
🇺🇸Missoula, Montana, 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
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
St. Thomas Hospital
🇬🇧London, United Kingdom
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Heart Center Research, LLC
🇺🇸Huntsville, Alabama, 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
Prairie Education and Research Cooperative
🇺🇸Springfield, Illinois, 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
🇺🇸Saint Louis, Missouri, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Newark Beth Israel Medical Center
🇺🇸Newark, New Jersey, United States
Moses H Cone Memorial Hospital
🇺🇸Greensboro, North Carolina, United States
Forsyth Medical Center
🇺🇸Winston-Salem, North Carolina, United States
Allegheny Singer Research Institute
🇺🇸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
Seton Medical Center
🇺🇸Austin, Texas, United States
Park Plaza Hospital
🇺🇸Houston, Texas, United States
University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States
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.)
🇨🇦Montréal, Quebec, Canada
Deutsches Herzzentrum München des Freistaates Bayern
🇩🇪München, Bavaria, Germany
Deutsches Herzzentrum Berlin
🇩🇪Berlin, Germany
Centro Cardiologico Monzino
🇮🇹Milano, Lombard, Italy
Santa Maria Hospital
🇵🇹Lisboa, Lisbon, Portugal
Kantonsspital St.Gallen
🇨🇭Saint Gallen, Stgalln, Switzerland