Phase
Condition
Stroke
Cerebral Ischemia
Treatment
Standard of Care PFO Closure Device
Investigational PFO Closure Device
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria: Subjects with a PFO and cryptogenic stroke:
PFO defined as visualization of microbubbles (during Trans Esophageal Echo (TEE)) inthe left atrium within three cardiac cycles of right atrial opacification at restand/or with Valsalva.
Cryptogenic stroke defined as a stroke of unknown cause.
Stroke defined as an acute focal neurological deficit, presumed to be due to focalischemia, and either:
Symptoms persisting ≥24 hours OR
Symptoms persisting <24 hours with Magnetic Resonance Imaging (MRI) or ComputerTomography (CT) findings of a new, neuroanatomically relevant, cerebral infarct.
Exclusion
Exclusion Criteria:
Age < 18 years
Myocardial Infarction (MI) or unstable angina within 6 months.
Severe mitral valve stenosis, severe aortic valve stenosis, or severe regurgitation.
Left Ventricle Ejection Fraction (LVEF) <35%.
Uncontrolled hypertension or diabetes mellitus despite medications.
Subjects contraindicated for aspirin or clopidogrel.
Presence of other comorbid conditions, or other medical, social, or psychologicalconditions that, in the investigator's opinion, could limit the subject's ability toparticipate in the clinical trial or to comply with follow up requirements, orimpact the scientific soundness of the clinical trial results.
Qualifying stroke with Modified Rankin score >3.
Anatomy in which the device would interfere with intracardiac or vascularstructures.
Life expectancy < 2 years.
Participation in another clinical study that can interfere with the results of thisstudy
Exclusion for patients with known causes of ischemic stroke:
Atrial fibrillation/atrial flutter (chronic or intermittent).
Left Ventricle (LV) aneurysm, intracardiac thrombus, or tumor.
Mitral or aortic valve vegetation or prosthesis.
Aortic arch plaques protruding >4 mm into the lumen.
Atherosclerosis or arteriopathy of intra- or extracranial vessels with >50% diameterstenosis in the artery supplying the infarcted territory.
Another cause of right-to-left shunting (e.g., an Atrial Septal Defect (ASD) or afenestrated atrial septum).
Presence of an arterial hypercoagulable state.
Lacunar infarct probably due to intrinsic small vessel as the qualifying event,defined as an ischemic stroke in the distribution of a single, small deeppenetrating vessel in a patient with any of the following:
A history of hypertension (except in the first week post stroke).
A history of diabetes mellitus.
Age ≥50 years.
MRI or CT with leukoaraiosis greater than symmetric, well-defined periventricularcaps, or bands (European Task Force on Age-Related White Matter Changes rating scalescore >0).
Arterial dissection as the qualifying event.
Study Design
Connect with a study center
University of Alberta Mazankowski Heart Institute
Edmonton, Alberta
CanadaSite Not Available
Vancouver General Hospital
Vancouver, British Columbia
CanadaSite Not Available
Ottawa Heart Institute
Ottawa, Ontario K1Y 4W7
CanadaSite Not Available
Toronto General Hospital
Toronto, Ontario
CanadaSite Not Available
Centre Hospitalier de l'Université de Montreal (CHUM)
Montréal, Quebec
CanadaSite Not Available
Institut de Cardiologie de Montréal
Montréal, Quebec
CanadaSite Not Available
Aarhus University Hospital
Aarhus,
DenmarkSite Not Available
Rigshospitalet Copenhagen
Copenhagen, 2100
DenmarkSite Not Available
Heart and Lung Center, Helsinki University Hospital
Helsinki,
FinlandSite Not Available
CHU Grenoble Alpes
La Tronche, 38700
FranceSite Not Available
Hôpital Privé Jacques Cartier
Massy, 91300
FranceSite Not Available
CHU Toulouse Rangueil
Toulouse, 31400
FranceSite Not Available
CardioVasculäre Centrum Frankfurt
Frankfurt, 60389
GermanySite Not Available
Asklepios Klinik Altona Hamburg
Hamburg, 22763
GermanySite Not Available
Universitaetsklinikum Hamburg-Eppendorf
Hamburg, 20246
GermanySite Not Available
Universitätsklinik Heidelberg
Heidelberg,
GermanySite Not Available
University Heart Center Lübeck
Lübeck, 23538
GermanySite Not Available
Amsterdam University Medical Center
Amsterdam,
NetherlandsSite Not Available
Erasmus Medical Center
Rotterdam,
NetherlandsSite Not Available
Erasmus University Medical Centre
Rotterdam,
NetherlandsSite Not Available
University Hospitals Sussex
Brighton, East Sussex
United KingdomSite Not Available
Royal Victoria Hospital
Belfast,
United KingdomSite Not Available
Arizona Cardiovascular Research Center
Phoenix, Arizona 85016
United StatesSite Not Available
Memorialcare Long Beach Medical Center
Long Beach, California 90806
United StatesSite Not Available
Keck School of Medicine of University of Southern California
Los Angeles, California 90033
United StatesSite Not Available
Stanford University Medical Center
Stanford, California 94305
United StatesSite Not Available
Los Robles Medical Center
Thousand Oaks, California 91360
United StatesSite Not Available
Colorado Heart and Vascular PC / St. Anthony Hospital
Lakewood, Colorado 80228
United StatesSite Not Available
South Denver Cardiology Associates
Littleton, Colorado 80120
United StatesSite Not Available
Medstar Washington Hospital Center
Washington, District of Columbia 20010
United StatesSite Not Available
Medstar Washington Hospital Center
Washington DC, District of Columbia 20010
United StatesSite Not Available
Rush University Medical Center
Chicago, Illinois 60612
United StatesSite Not Available
OSF Saint Francis Medical Center
Peoria, Illinois 61637
United StatesSite Not Available
University of Louisville
Louisville, Kentucky 40202
United StatesSite Not Available
Cardiovascular Institute of the South
Houma, Louisiana 70360
United StatesSite Not Available
MaineHealth
Portland, Maine 04102
United StatesSite Not Available
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
United StatesSite Not Available
Massachusetts General Hospital
Boston, Massachusetts 02114
United StatesSite Not Available
Tufts New England Medical Center
Boston, Massachusetts 02111
United StatesSite Not Available
Baystate Medical Center
Springfield, Massachusetts 01199
United StatesSite Not Available
University of Michigan
Ann Arbor, Michigan 48109
United StatesSite Not Available
Essentia Health
Duluth, Minnesota 55804
United StatesSite Not Available
University of Nebraska Medical Center
Omaha, Nebraska 68198
United StatesSite Not Available
Virtua Our Lady of Lourdes
Marlton, New Jersey 080653
United StatesSite Not Available
The Valley Hospital
Paramus, New Jersey 07652
United StatesSite Not Available
Atrium Health Sanger Heart and Vascular Institute
Charlotte, North Carolina 28204
United StatesSite Not Available
University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106
United StatesSite Not Available
Ohio Health Research Institute
Columbus, Ohio 43214
United StatesSite Not Available
The Ohio State University
Columbus, Ohio 43210
United StatesSite Not Available
Oklahoma Heart Hospital
Oklahoma City, Oklahoma 73120
United StatesSite Not Available
Oregon Health & Science University
Portland, Oregon 97239
United StatesSite Not Available
UPMC Presbyterian
Pittsburgh, Pennsylvania 15213
United StatesSite Not Available
Vanderbilt Medical Center
Nashville, Tennessee 37232
United StatesSite Not Available
HCA Houston Healthcare Medical Center
Houston, Texas 77004
United StatesSite Not Available
UTHealth Houston
Houston, Texas 77030
United StatesSite Not Available
University of Texas Health Science Center at Houston
Houston, Texas 77030
United StatesSite Not Available
Sentara Health Research Center
Norfolk, Virginia 23507
United StatesSite Not Available
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