Condition: Ischemic Stroke · Embolic Stroke of Undetermined Source · Patent Foramen Ovale (PFO) · Sponsor: Taichung Veterans General Hospital
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 …
This description comes directly from the study's public registry record.
Chi-Sheng Wang, MD · +886933375721 · sam7227632@gmail.com
I-Hui Lee, MD, PhD · +886-4-23592525 · ihui_lee@hotmail.com
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| Taichung Veterans General Hospital | Taichung, Taiwan | Recruiting |
| National Taiwan University Hospital | Taipei, Taiwan | Recruiting |
| Taipei Veterans General Hospital | Taipei, Taiwan | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07479147