Comparing PFO closure with blood thinners after stroke in older adults
Compares PFO closure with blood thinners in older adults after a stroke.
Plain-language title generated from the registry record
Registry title: SENIOR: Stroke Prevention in the Elderly by Patent Foramen Ovale closuRe vs Anticoagulation
Key facts
- Where
- Taichung and Taipei, TaiwanSee the 3 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 90 years old?
Source: NCT07479147, who can take part
Where in Taiwan
- Taichung Veterans General HospitalTaichung, TaiwanTaking people
- National Taiwan University HospitalTaipei, TaiwanTaking people
- Taipei Veterans General HospitalTaipei, TaiwanTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Taichung Veterans General Hospital
- Trial code
- NCT07479147
- Record updated
- 23 March 2026
- Original description
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.Read full original descriptionShow less
Patent Foramen Ovale-Related Stroke Management and Outcome: Age-dependent Risk Prediction and Atrial Cardiopathy Study (SENIOR Study)
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 are 400 (prospective) and 500 (retrospective). We will enroll adults with ESUS and PFO; the prospective arm will focus on patients aged >60 years with PFO related stroke. Treatments will be assigned as PFO closure, standard-dose DOAC, or antiplatelet agents (if DOAC intolerance) by local principal investigator. The primary outcome is recurrent ischemic stroke or transient ischemic attack. Secondary outcomes include 6-month functional outcome, all stroke, and serial comparison of atrial cardiopathy changes. Safety endpoints include peri-procedural adverse events (including newly-onset atrial fibrillation), hemorrhagic stroke, and all caused mortality. Clinical presentation, imaging, cardiac testing, biomarker, and genetic data will be collected for stratified and multivariable analyses.
Inclusion: 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: Known stroke mechanism was diagnosed; Follow-up less than 6 months; Extracardiac right-to-left shunt.