Medical Treatment With or Without Transcatheter Patent Foramen Ovale Closure
Trial Parameters
Brief Summary
Patent foramen ovale PFO closure has been shown to reduce the risk of stroke in patients with recurrent stroke. However, the majority of existing clinical studies in this field excluded patients over the age of 60 years. Data in older patients is limited and since the population ages and stroke remains a major cause of death and morbidity, randomized clinical trials are needed to better assess the benefit of PFO closure in this elderly population. Therefore, this study proposal sought to determine the efficacy of PFO closure for the prevention of recurrent stroke in older patients with PFO and cryptogenic stroke.
Eligibility Criteria
Inclusion Criteria: * Cryptogenic stroke * Age \>60 years * Right-to-left shunt as evaluated by echocardiography (TEE). Exclusion Criteria: -≤60 year-old * Lacunar (small vessel) stroke. * Permanent or paroxysmal atrial fibrillation/flutter (clinically apparent or detected by continuous ECG monitoring). * Need for chronic anticoagulation therapy. * Any contraindication for antiplatelet therapy (aspirin, clopidogrel, ticagrelor). * Presence of extracranial or intracranial atherosclerosis causing ≥50% luminal --stenosis in arteries supplying the area of ischemia. * Presence of complex atheroma plaques at the ascending aorta-aortic arch (≥4-mm-thick, ulcerated or containing mobile thrombi) as evaluated by TEE. * Presence of intracardiac thrombus as evaluated by TEE. * Uncontrolled hypertension (systemic pressure values \>160/90 mmHg despite optimal medical treatment). * History of myocardial infarction or coronary intervention. (percutaneous coronary intervention, coronary artery bypass g