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

Summary

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.

Conditions

• Ischemic Stroke
• Embolic Stroke of Undetermined Source
• Patent Foramen Ovale (PFO)
• Elderly

Interventions

DEVICE

PFO closure

Transcatheter PFO closure by Amplatzer PFO occluder plus long-term antiplatelet (dual antiplatelet for at least 3 month and life-long single antiplatelet )

DRUG

Medication

Standard dose direct oral anticoagulant (DOAC) or Antiplatelet if protocol-defined DOAC ineligibility 1. Unavoidable and non-substitutable severe drug interaction 2. Newly onset on-label contraindication 3. Patient refusal of DOAC

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan

  collaborator OTHER_GOV

• National Taiwan University Hospital

  collaborator OTHER

• Taichung Veterans General Hospital

  lead OTHER

Principal Investigators

• I-Hui Lee, MD, PhD · Taipei Veterans General Hospital, Taiwan

• Chi-Sheng Wang, MD · Taichung Veterans General Hospital

• Sung-Chun Tang, MD, PhD · National Taiwan University Hospital

Eligibility

Min Age

18 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-12-16

Primary Completion

2031-12-31

Completion

2031-12-31

Countries

• Taiwan

Study Locations