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

Recruitingn/aAges 18 Years - 90 YearsAllTaichung Veterans General Hospital
NCT07479147 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Patent foramen ovale (PFO) is an important mechanism of embolic stroke of undetermined source (ESUS). Current guidelines recommend PFO closure for high-risk PFO in patients younger than 60 years, and a recent retrospective cohort study from Taichung Veterans General Hospital has shown that closure is effective and safe in older adults; however, the optimal treatment strategy for those \>60 years and direct head-to-head comparisons of PFO closure versus direct oral anticoagulants (DOACs) remain insufficient. Robust evidence from a multicenter study combining prospective and retrospective cohorts is warranted. The SENIOR study is a multicenter observational cohort registry with a combined retrospective and prospective design. The prospective period is from September 15, 2025 to December 31, 2031, and the retrospective period covers January 1, 2013 to September 1, 2025; target sample sizes

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📋 Eligibility rules (as published)
Inclusion Criteria: * Patient or his/her legal representative signs a written informed consent * Participants who have diagnosed as PFO related stroke * For patient aged 18-59: patient with high risk PFO feature or RoPE score ≥ 7 * For patient aged 60-90: patient with high risk PFO feature or RoPE score ≥ 4, must include cortical infarct Exclusion Criteria: * Follow-up less than 6 months * Extracardiac right-to-left shunt * Known stroke mechanism was diagnosed
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What it tests

  • PFO closure
  • Medication
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Where

3 sites
Taichung Veterans General Hospital
Taichung, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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