Phase
Condition
Blood Clots
Cerebral Ischemia
Stroke
Treatment
FDA-approved PFO closure device
Encore PFO closure device
Clinical Study ID
Ages 18-60 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Diagnosis of PFO, defined as visualization of microbubbles per TEE in the leftatrium within three cardiac cycles from the right atrial opacification demonstratingright-to-left shunting at rest and/or during Valsalva release
Cryptogenic stroke within the last 270 days; stroke is defined as acute focalneurological deficit, presumed to be due to focal ischemia, and confirmed by MRI orCT to be a new, neuroanatomically relevant cerebral infarct
Exclusion
Exclusion Criteria:
Age <18 years and age >60 years
Greater than 50% lumen diameter stenosis of intracranial or extracranial vessels
Intracardiac thrombus or tumor
Acute or recent (within 6 months) myocardial infarction (MI) or unstable angina
Left ventricular aneurysm or akinesis
Mitral valve stenosis (mitral valve area less than 1.5cm2) or severe mitralregurgitation
Aortic valve stenosis (gradient >40 mmHg) or severe aortic valve regurgitation
Mitral or aortic valve vegetation or prosthesis
Left ventricular ejection fraction <35%
Other identifiable cause of stroke, including but not limited to aortic arch plaques (protruding >4 mm into the lumen), large artery atherosclerotic disease, anestablished cardioembolic source, small-vessel occlusive disease, or arterialdissection
Evidence of a hypercoagulable disorder requiring anticoagulation therapy; thisdetermination will be based on the evaluation of: anticardiolipin antibody (Ab) ofthe IgG or IgM type, Lupus anticoagulant, B2-glycoprotein-1 Ab, and fasting plasmahomocysteine
Another source of right-to-left shunts identified at baseline, including an atrialseptal defect and/or fenestrated septum
Any history of atrial fibrillation/atrial flutter (chronic or intermittent)
Active endocarditis or other untreated infections
Chronic kidney disease stage 4 or higher or end-stage renal failure requiringdialysis (eGFR less than 30)
Severe liver disease (ALT 3X ULN) or documented cirrhosis
Lung disease requiring continuous home oxygen
Uncontrolled hypertension, defined as sustained elevated blood pressure >160/90 mmHg on medication
Uncontrolled diabetes mellitus, defined as HbA1c greater than 9 (based on mostrecent test which must have been collected within the last year)
Anatomical or physiological structures that do not permit TEE
Anticipated need for treatment of structural cardiac defects other than PFO
Concomitant cardiac anomalies requiring an operative procedure
Hemorrhagic diseases (e.g., coagulopathy, tendency to hemolysis)
Hypersensitivity to contrast medium or nickel
Contraindication to aspirin or clopidogrel
The required sheaths cannot be passed through the relevant vessels for access to thePFO
Vulnerable patient (e.g., incarcerated or cognitively challenged adults); seeSection 7.2.1
Subject is unable or unwilling to provide informed consent
Subject is unable to comply with the protocol
Any other clinical reasons for which the patient would not be an appropriatecandidate for the study, as determined by the site investigators
Study Design
Study Description
Connect with a study center
Arkansas Cardiology
Little Rock, Arkansas 72205
United StatesActive - Recruiting
Southern CA Permanente Medical Group - Kaiser San Diego and Scripps Memorial Hospital
La Jolla, California 92037
United StatesActive - Recruiting
University of South Florida
Tampa, Florida 33606
United StatesActive - Recruiting
Mercy One Iowa Heart Center
West Des Moines, Iowa 50266
United StatesActive - Recruiting
Kansas University Medical Center
Kansas City, Kansas 66160
United StatesActive - Recruiting
Jackson Heart Clinic
Jackson, Mississippi 39216
United StatesActive - Recruiting
CHI Health
Omaha, Nebraska 68124
United StatesActive - Recruiting
Medical University of South Carolina Gazes Research Institute
Charleston, South Carolina 29425
United StatesActive - Recruiting
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