Prospective Registry of Elderly Patients With ESUS to Evaluate the Role of Covert Atrial Fibrillation and Patent Foramen Ovale

What this Trial Is About

This research focuses on elderly patients over 60 years old who have experienced an embolic stroke of undetermined source (ESUS) and have a high-risk patent foramen ovale (PFO). Researchers are evaluating the effectiveness of PFO closure combined with standard antiplatelet treatment compared to antiplatelet treatment alone in preventing stroke recurrence in this older population, as the benefit of PFO closure in elderly patients remains unclear. Participants will be observed and monitored for paroxysmal atrial fibrillation for 3 to 6 months using an insertable loop recorder or other heart monitoring methods based on physician decision. Depending on clinical assessment, patients will either receive PFO closure along with standard antiplatelet therapy (aspirin and clopidogrel) or standard antiplatelet therapy alone. If atrial fibrillation is detected, anticoagulation treatment may be considered. During the study, patients will have ongoing heart rhythm monitoring and regular clinical evaluations over at least one year to measure outcomes such as ischemic stroke recurrence, major adverse cardiovascular events, hemorrhagic stroke, vascular death, myocardial infarction, atrial fibrillation episodes, and major bleeding. Researchers will track treatment adherence and safety while following patients for long-term effects.

Prospective Registry of Elderly ESUS With PFO