Comparing Two PFO Closure Devices in Adults With Previous Stroke or TIA

Korábbi kezelés

• Previous intracardiac surgery or percutaneous PFO-closure
• Contraindications to anticoagulants or antiplatelet drugs, either before or after the PFO closure procedure
• Patient is currently participating in another investigational drug or device study that has not reached its primary endpoint yet

Más betegség

• Patients who have definite causes of stroke or transient ischemic attack unrelated to the PFO
• Active endocarditis or other untreated infectious diseases
• Left ventricular aneurysm or akinesis Myocardial infarction or unstable angina pectoris within 12 months
• Patients with non-embolic cryptogenic stroke (for example lacunar stroke) or with other identifiable causes of stroke, including but not limited to aortic arch plaques (protruding >4 mm into the lumen), large artery atherosclerotic disease, an established cardioembolic source, small-vessel occlusive disease, or arterial dissection
• Glomerular filtration rate < 30 ml/min/1.73 m2 or with any history of renal dialysis or renal transplantation
• Severe pulmonary disease including pulmonary hypertension (clinical diagnosis)
• Uncontrollable hypertension or diabetes mellitus
• Patients diagnosed with a neurological disease that causes progressive neurological dysfunction
• Malignant tumors or other serious diseases resulting in a life expectancy of less than 12 months
• Psychiatric conditions that may interfere with medical compliance and compliance with follow-up
• Patient with any medical condition that would make him/her inappropriate for treatment as per the current IFU of respective devices or in the opinion of the Investigator
• Stroke with poor outcome at time of enrollment (Modified Rankin score >3)

Laborértékek

• Left ventricular ejection fraction (LVEF) <35%
• Severe liver function impairment (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 3 times the upper limit of normal value）

Egyéb

• RLS caused by other causes, such as atrial septal defect or pulmonary arteriovenous shunt
• Patients with atrial fibrillation/atrial flutter (chronic or intermittent) Intracardiac thrombus or tumor
• Patients with mitral or aortic valve stenosis or severe regurgitation
• Mitral or aortic valve vegetation or prosthesis
• Dilated cardiomyopathy, hypertrophic cardiomyopathy, restrictive cardiomyopathy
• Atherosclerosis or arteriopathy of intra- or extracranial vessels with >50% diameter stenosis in the artery supplying the infarcted territory.
• Active or planned (within 12 months) pregnancy, or lactating female patients
• Patients with hypercoagulable states
• Anatomy in which the device would interfere with intracardiac or vascular structures
• Inability to obtain Informed Consent from patient or legally authorized representatives
• Subjects who will not be available for follow up for the duration of the trial

• Patients with >18 years of age and <65 years of age, regardless of gender
• Patients with normal or aneurysm type PFO confirmed by imaging examination [Transthoracic Echocardiography (TTE)/ Transesophageal Echocardiography (TOE) or Intracardiac Echocardiography], and who exhibit spontaneous right-to-left shunting or right-to-left shunting during Valsalva maneuver.
• Patients with history of cryptogenic embolic stroke or transient ischemic attack in the previous 12 months [stroke is defined as acute focal neurological deficit presumed to be due to focal ischemia, and either 1) symptoms persisting 24 hours or greater, or 2) symptoms persisting less than 24 hours but associated with MR or CT findings of a new, neuroanatomically relevant, cerebral infarct. Transient Ischemic Attack is defined as acute focal neurological deficit (defined as focal motor deficit, aphasia, difficulty walking, hemisensory deficit, amaurosis fugax, blindness, or focal visual deficit) presumed due to focal ischemia, lasting between 5 minutes and 24 hours, that is not associated with MR or CT findings of a new cerebral infarct]. The diagnosis of cryptogenic embolic stroke or TIA has to be confirmed by a neurologist.
• The size of PFO must be amenable to selection of a Cocoon PFO Occluder or Amplatzer PFO closure device.
• Patients are informed of the nature of the trial and agree to all requirements for participation in the trial, signed the informed consent form, and agreed to complete the follow-up and follow-up examination