Evaluating Transcatheter Closure Versus Medical Treatment for Preventing Stroke Recurrence in Older Adults With Cryptogenic Stroke and Patent Foramen Ovale

What this Trial Is About

Researchers are investigating the effectiveness of closing a patent foramen ovale PFO to prevent recurrent stroke in older patients who have had a cryptogenic stroke, a type of stroke with an unknown cause. While previous studies have shown PFO closure benefits in younger patients under 60, data for patients over 60 is limited. This trial aims to provide clear evidence on whether PFO closure reduces stroke risk in this older population. The study compares two groups one receiving transcatheter PFO closure plus optimal medical treatment, and the other receiving only optimal medical treatment. Both groups will be given antithrombotic agents single antiplatelet treatment and management of vascular risk factors like dyslipidemia, hypertension, and diabetes according to stroke prevention guidelines. The PFO closure procedure will use approved occluder devices and be performed by experienced centers. Participants will be monitored for ischemic events over 12 months, with additional assessments planned over a 10-year follow-up. Researchers will evaluate stroke rates, mortality, cardiovascular mortality, cerebral hemorrhage, new atrial fibrillation, bleeding, quality of life, and cognitive function. The study involves regular health checks and long-term follow-up to assess the outcomes and safety of the interventions.

Medical Treatment With or Without Transcatheter Patent Foramen Ovale Closure