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

NCT07479147 | Recruiting DMC

• 1 other identifier: SENIOR study
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

patent foramen ovale; patent foramen ovale closure; embolic stroke of undetermined source; elderly; multi-center; anticoagulation

Outcome Measures

Primary Outcomes (1)

• Recurrent acute ischemic stroke (AIS) or transient ischemic attack (TIA)

  AIS: Diagnosed by Neurologist by standard pathway TIA: Hemiplegia, lasting for \> 10 minutes and documented by Neurologist

  3 year follow-up, at least > 6 months, event-driven

Secondary Outcomes (4)

• All strokes and all-cause mortality

  3 year follow-up, at least > 6 months, event-driven

• Functional outcome

  6 months

• Atrial cardiopathy (optional)

  12 months

• Safety outcome

  3 year follow-up, at least > 6 months, event-driven

Study Arms (4)

Non-elderly, medication

Patient with age \< 60 year-old, received standard dose DOAC or antiplatelet if protocol-defined DOAC ineligibility

Drug: Medication

Non-elderly, PFO closure

Patient with age \< 60 year-old, received PFO closure plus antiplatelet

Device: PFO closure

Elderly, medication

Patient with age ≥ 60 year-old, received standard dose DOAC or antiplatelet if protocol-defined DOAC ineligibility

Drug: Medication

Elderly, PFO closure

Patient with age ≥ 60 year-old, received PFO closure plus antiplatelet

Device: PFO closure

Interventions

PFO closure DEVICE

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

Also known as: closure

Elderly, PFO closure; Non-elderly, PFO closure

Medication DRUG

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

Elderly, medication; Non-elderly, medication

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with recent embolic stroke of undetermined source and patent foramen ovale (PFO)

You may qualify if:

• 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

You may not qualify if:

• Follow-up less than 6 months
• Extracardiac right-to-left shunt
• Known stroke mechanism was diagnosed

Sponsors & Collaborators

• Taichung Veterans General Hospital: lead
• Taipei Veterans General Hospital, Taiwan: collaborator
• National Taiwan University Hospital: collaborator

Study Sites (3)

Taichung Veterans General Hospital

Taichung, 40705, Taiwan

RECRUITING

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

Taipei Veterans General Hospital

Taipei, 100, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

This study will incorporate patients' genetic testing results as part of secondary outcome analyses focusing on genetic risk. Genetic testing modalities may include genome-wide genotyping array (TPM 2.0 array), whole exome sequencing (WES), or whole genome sequencing (WGS), as determined by the principal investigator at each participating center. Genetic testing will be performed using peripheral blood samples, which will be collected concurrently with routine blood sampling conducted during standard stroke evaluation.

MeSH Terms

Conditions

Ischemic Stroke; Foramen Ovale, Patent

Interventions

Dosage Forms

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Heart Septal Defects, Atrial; Heart Septal Defects; Heart Defects, Congenital; Cardiovascular Abnormalities; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques

Study Officials

• I-Hui Lee, MD, PhD

  Taipei Veterans General Hospital, Taiwan

  PRINCIPAL INVESTIGATOR

• Chi-Sheng Wang, MD

  Taichung Veterans General Hospital

  STUDY DIRECTOR

• Sung-Chun Tang, MD, PhD

  National Taiwan University Hospital

  STUDY DIRECTOR

Central Study Contacts

Chi-Sheng Wang, MD

CONTACT

+886933375721; sam7227632@gmail.com

I-Hui Lee, MD, PhD

CONTACT

+886-4-23592525; ihui_lee@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Attending Physician of Cerebralvascular department, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: March 13, 2026
• First Posted: March 18, 2026
• Study Start: December 16, 2025
• Primary Completion (Estimated): December 31, 2031
• Study Completion (Estimated): December 31, 2031
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: following paper publication without end date
• Access Criteria: on reasonable request from the principal investigator

Locations

TW (3)