SENIOR Study on Stroke Prevention in Older Adults with Patent Foramen Ovale Comparing Closure Device and Anticoagulant Medication

What this Trial Is About

This research focuses on patients with embolic stroke of undetermined source ESUS linked to patent foramen ovale PFO, particularly addressing the treatment gap for those aged 60 years and older. It aims to compare the safety and effectiveness of PFO closure against direct oral anticoagulants DOACs or antiplatelet agents for preventing recurrent strokes. The study combines a retrospective cohort from 2013 to 2025 and a prospective cohort from 2025 to 2031, involving approximately 900 adults aged 18 to 90 years with ESUS and confirmed PFO. Participants receive treatments determined by local investigators, including transcatheter PFO closure using the Amplatzer device plus antiplatelet therapy, standard-dose DOACs, or antiplatelet drugs when DOACs are contraindicated. The prospective arm emphasizes patients aged 60 and above with high-risk PFO features. Treatment groups include younger or older patients receiving either medical therapy alone or PFO closure with antiplatelet therapy. During the study, participants undergo clinical evaluations, imaging, cardiac tests, biomarker and genetic data collection, and optional atrial cardiopathy assessments over 3 years. Researchers monitor recurrent ischemic stroke or transient ischemic attack as the primary outcome, alongside functional outcomes, all stroke events, safety endpoints like new atrial fibrillation, and mortality. This comprehensive data collection aims to improve risk prediction and guide individualized treatment choices for PFO-related stroke.

SENIOR: Stroke Prevention in the Elderly by Patent Foramen Ovale closuRe vs Anticoagulation