Clinical trial NCT03309332: AMPLATZER PFO Occluder Post Approval Study
Official title: OSB Lead-AMPLATZER PFO Occluder New Enrollment PAS
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Stroke
Patent Foramen Ovale
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2017-10-13
Enrollment: 1214
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

• Subjects with a PFO who have had an ischemic stroke within the last 547 days

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Primary Effectiveness: 5 year rate of recurrent ischemic stroke
timeFrame: Through 5 years
measure: Primary Safety: Device or procedure related serious adverse events
timeFrame: Through 30 days post implant
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Huntsville
country: United States
facility: Heart Center Research, LLC
state: Alabama
city: Chandler
country: United States
facility: Chandler Regional Medical Center
state: Arizona
city: Phoenix
country: United States
facility: St. Joseph's Hospital and Medical Center
state: Arizona
city: Scottsdale
country: United States
facility: Scottsdale Healthcare Shea
state: Arizona
city: Tucson
country: United States
facility: Pima Heart Physicians, PC
state: Arizona
city: Little Rock
country: United States
facility: UAMS Medical Center
state: Arkansas
city: Los Angeles
country: United States
facility: Kaiser Permanente Los Angeles Medical Center
state: California
city: Los Angeles
country: United States
facility: USC University Hospital
state: California
city: Los Angeles
country: United States
facility: Ronald Reagan UCLA Medical Center
state: California
city: Sacramento
country: United States
facility: Sutter Medical Center
state: California
city: San Diego
country: United States
facility: San Diego Cardiac Center
state: California
city: San Francisco
country: United States
facility: University of California at San Francisco
state: California
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Thousand Oaks
country: United States
facility: Los Robles Hospital and Medical Center
state: California
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
city: Colorado Springs
country: United States
facility: Memorial Hospital of Colorado Springs
state: Colorado
city: Denver
country: United States
facility: Denver Heart
state: Colorado
city: Littleton
country: United States
facility: South Denver Cardiology Associates PC
state: Colorado
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Jacksonville
country: United States
facility: St. Vincent's Medical Center
state: Florida
city: Jacksonville
country: United States
facility: Baptist Medical Center
state: Florida
city: Jacksonville
country: United States
facility: First Coast Cardiovascular Institute
state: Florida
city: Orlando
country: United States
facility: Orlando Health
state: Florida
city: Weston
country: United States
facility: Cleveland Clinic Florida
state: Florida
city: Augusta
country: United States
facility: Augusta University
state: Georgia
city: Gainesville
country: United States
facility: Northeast Georgia Medical Center
state: Georgia
city: Marietta
country: United States
facility: WellStar Kennestone Hospital
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Springfield
country: United States
facility: Prairie Education and Research Cooperative
state: Illinois
city: Overland Park
country: United States
facility: HCA Midwest Division, Menorah Medical Center
state: Kansas
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Louisville
country: United States
facility: Baptist Hospital East
state: Kentucky
city: New Orleans
country: United States
facility: Ochsner Medical Center
state: Louisiana
city: Baltimore
country: United States
facility: Johns Hopkins University Hospital
state: Maryland
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Fall River
country: United States
facility: Charlton Memorial Hospital
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts Medical Center
state: Massachusetts
city: Auburn Hills
country: United States
facility: McLaren Health Care Corporation
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Detroit
country: United States
facility: Children's Hospital of Michigan
state: Michigan
city: Lansing
country: United States
facility: Sparrow Clinical Research Institute
state: Michigan
city: Duluth
country: United States
facility: St. Mary's Hospital
state: Minnesota
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute
state: Minnesota
city: Saint Cloud
country: United States
facility: St. Cloud Hospital
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Saint Louis
country: United States
facility: Mercy Hospital South
state: Missouri
city: Missoula
country: United States
facility: St. Patrick Hospital
state: Montana
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Newark
country: United States
facility: Newark Beth Israel Medical Center
state: New Jersey
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: New York
country: United States
facility: New York Presbyterian Hospital/ Cornell University
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Medical Center
state: New York
city: Charlotte
country: United States
facility: Novant Health Heart and Vascular Research
state: North Carolina
city: Greensboro
country: United States
facility: Moses H Cone Memorial Hospital
state: North Carolina
city: Winston-Salem
country: United States
facility: Forsyth Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: Jewish Hospital
state: Ohio
city: Cincinnati
country: United States
facility: TriHealth Bethesda North Hospital
state: Ohio
city: Columbus
country: United States
facility: Ohio Health Research Institute
state: Ohio
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Columbus
country: United States
facility: Mt Carmel East
state: Ohio
city: Clackamas
country: United States
facility: Kaiser Sunnyside Medical Center
state: Oregon
city: Portland
country: United States
facility: Providence Heart and Vascular Institute
state: Oregon
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
city: Hershey
country: United States
facility: Penn State Milton S Hershey Medical Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny Singer Research Institute
state: Pennsylvania
city: West Columbia
country: United States
facility: Lexington Medical Center
state: South Carolina
city: Sioux Falls
country: United States
facility: Sanford USD Medical Center
state: South Dakota
city: Chattanooga
country: United States
facility: Erlanger Medical Center
state: Tennessee
city: Knoxville
country: United States
facility: Tennova Healthcare - Turkey Creek Medical Center
state: Tennessee
city: Austin
country: United States
facility: Seton Medical Center
state: Texas
city: Houston
country: United States
facility: Park Plaza Hospital
state: Texas
city: Houston
country: United States
facility: University of Texas Health Science Center at Houston
state: Texas
city: Plano
country: United States
facility: The Heart Hospital Baylor Plano
state: Texas
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
city: Seattle
country: United States
facility: Swedish Medical Center - Heart & Vascular
state: Washington
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
city: Madison
country: United States
facility: University of Wisconsin Hospital
state: Wisconsin
city: Milwaukee
country: United States
facility: Aurora Medical Group
state: Wisconsin
city: Calgary
country: Canada
facility: Foothills Medical Centre
state: Alberta
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
city: Montréal
country: Canada
facility: Institut de Cardiologie de Montreal (Montreal Heart Inst.)
state: Quebec
city: München
country: Germany
facility: Deutsches Herzzentrum München des Freistaates Bayern
state: Bavaria
city: Berlin
country: Germany
facility: Deutsches Herzzentrum Berlin
city: Milano
country: Italy
facility: Centro Cardiologico Monzino
state: Lombard
city: Lisboa
country: Portugal
facility: Santa Maria Hospital
state: Lisbon
city: Saint Gallen
country: Switzerland
facility: Kantonsspital St.Gallen
state: Stgalln
city: London
country: United Kingdom
facility: St. Thomas Hospital
Study officials:
affiliation: Abbott
name: Barathi Sethuraman, PhD
role: STUDY_DIRECTOR
References: