PFO closure versus blood thinners to prevent repeat stroke in older adults
Official title: Patent Foramen Ovale-Related Stroke Management and Outcome: Age-dependent Risk Prediction and Atrial Cardiopathy Study (SENIOR Study)
Run by Taichung Veterans General Hospital · NCT07479147 · Data updated 2026-11-12
This study will test whether closing a patent foramen ovale or taking direct oral anticoagulants better prevents repeat strokes in adults over 60 with PFO-related embolic stroke.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 90 Years |
| Sex | All |
| Enrollment | 400 (estimated) |
| Sponsor | Taichung Veterans General Hospital Academic / other |
| Locations | 3 sites (Taichung and 2 other locations) |
| Status | Recruiting |
| Started | December 16, 2025 |
| Main results expected | December 31, 2031 |
| Study ends | December 31, 2031 |
| Registry record updated | March 23, 2026 |
| Trial ID | NCT07479147 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults diagnosed with ESUS and PFO—especially those over 60 with high-risk PFO features or a RoPE score ≥4 with cortical infarct, and younger adults with high-risk features or RoPE ≥7.
✕Probably not a fit
Patients whose stroke has a known alternative mechanism, those with extracardiac right-to-left shunts, or those unable to complete at least six months of follow-up are unlikely to benefit from the study findings.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
SENIOR is a multicenter hybrid registry combining retrospective (2013–2025) and prospective (Sept 15, 2025–Dec 31, 2031) cohorts to compare outcomes after PFO closure versus medical therapy including DOACs in patients with ESUS and PFO. The registry aims to enroll about 900 patients (500 retrospective, 400 prospective) from three major Taiwanese centers and will collect clinical, imaging, procedural, and follow-up data with a minimum 6-month follow-up. Inclusion focuses on adults with ESUS and PFO, with specific age- and RoPE-based criteria to select high-risk PFOs in both younger and older patients, while excluding extracardiac shunts and known non-PFO stroke mechanisms. Analyses will compare recurrent stroke rates and safety outcomes between closure and anticoagulation groups, and explore age-dependent risk prediction and markers of atrial cardiopathy.
Why it matters
Potential benefit: If successful, the results could clarify whether closure or modern anticoagulation better prevents recurrent stroke in older patients with PFO and guide treatment decisions.
How similar studies have gone: Randomized trials have shown benefit of PFO closure in selected patients under 60, and retrospective single-center data suggest closure can be effective and safe in older adults, but prospective head-to-head comparisons with DOACs are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Taichung Veterans General Hospital
Taichung, Taiwan Recruiting -
National Taiwan University Hospital
Taipei, Taiwan Recruiting -
Taipei Veterans General Hospital
Taipei, Taiwan Recruiting
Study contacts
- Principal investigator: I-Hui Lee, MD, PhD — Taipei Veterans General Hospital, Taiwan
- Study coordinator: Chi-Sheng Wang, MD
- Email: sam7227632@gmail.com
- Phone: +886933375721
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.