PFO closure versus blood thinners to prevent repeat stroke in older adults
Patent Foramen Ovale-Related Stroke Management and Outcome: Age-dependent Risk Prediction and Atrial Cardiopathy Study (SENIOR Study)
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 |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Taichung Veterans General Hospital Academic / other |
| Locations | 3 sites (Taichung and 2 other locations) |
| Trial ID | NCT07479147 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Taichung and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.