Evaluating Percutaneous Repair Of The Atrial Septum With A Novel PFO Occluder: The PROTEA-PFO OUS Study

Ki vehet részt

• Patient must be ≥ 18 and ≤ 65 years of age
• Diagnosis of PFO, defined as visualization of microbubbles per TEE in the left atrium within three cardiac cycles from the right atrial opacification demonstrating right-to-left shunting at rest and/or during Valsalva release
• Ischemic stroke, defined as acute focal neurological deficit, presumed to be due to focal ischemia and confirmed by MRI or CT to have a neuroanatomically relevant cerebral infarct
• Modified Rankin score (mRS) ≤ 3
• Appropriate PFO anatomy for implantation of the investigational device as evaluated and determined by independent committee
• Patient is willing and capable of providing informed consent
• Prior to index procedure (7-day window), persons of childbearing potential must have a negative pregnancy test

Ki nem vehet részt

• Myocardial Infarction (MI) or unstable angina within the previous 180 days
• Active endocarditis or other infection that may preclude implantation of the investigational device
• Known hypercoagulable state that would require full anticoagulation. Minimum testing to include lupus anticoagulant, anticardiolipin antibodies, beta-2-glycoprotein, homocysteine
• Any disorder in the investigator's opinion that could interfere with compliance of safety evaluation or require premature discontinuation of antiplatelet regime post-implantation, as well as any severe concurrent illness that would limit life expectancy (e.g., malignancies)
• Currently an active subject in an investigational drug or device study that could confound the results of this study
• Any prior percutaneous cardiovascular intervention for AF ablation
• Other identifiable causes of stroke, including but not limited to aortic arch plaques (protruding >4 mm into the lumen), large artery atherosclerotic disease proximal to the territory of the index stroke, an established cardioembolic source, small-vessel occlusive disease, or arterial dissection, presence of left atrial appendage thrombus
• Other arteriopathy of the intracranial or extracranial vessels with >50% stenosis proximal to the territory of the index stroke
• History of atrial tachycardia, atrial fibrillation or flutter, AV block, or ventricular arrhythmia requiring antiarrhythmic medication, pacemaker, or AICD
• Severe liver disease (e.g., documented cirrhosis or active hepatitis)
• Severe lung insufficiency (e.g., need for supplemental oxygen or chronic steroid medications)
• Uncontrolled hypertension, defined as sustained elevated blood pressure >140/90 mm Hg
• Severe pulmonary artery hypertension, defined as pulmonary systolic pressure of >50mmHg
• Increased bleeding risk such as severe liver failure, active peptic ulcer, proliferative diabetic retinopathy, history of severe bleeding (e.g.: gastrointestinal bleeding, macroscopic hematuria, intraocular bleeding, intracranial or cerebral hemorrhage), or other history of bleeding or coagulopathy
• Subjects not able to discontinue anticoagulation for indications other than then index stroke
• Any significant valve dysfunction that contraindicates PFO closure or increased pulmonary vascular resistance/severe pulmonary hypertension
• Known nickel allergy that, in the opinion of the investigator, poses a safety risk with regards to participation in the trial
• Left ventricular dilated cardiomyopathy with LVEF <35%
• Severe renal failure ( Stage 4 CKD, eGFR <30) or patient requiring dialysis
• Uncontrolled hyperglycemia, defined as HbA1c value >8% (IFCC: >64 mmol/mol)
• Life expectancy < 2 years
• Intracardiac thrombus or tumor
• Left ventricular aneurysm or akinesis
• Moderate to severe mitral valve stenosis or severe mitral regurgitation
• Aortic valve stenosis (mean gradient >20 mmHg) or severe regurgitation
• Any valve vegetation or Lambl's excrescence of any left-sided valve
• Another source of right-to-left shunts identified at baseline, including an atrial septal defect and/or fenestrated septum and pulmonary arteriovenous malformation
• Subjects contraindicated for aspirin or clopidogrel
• Contraindication for transesophageal echocardiography (TEE) or intracardiac echocardiography (ICE)