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Evaluation of Prevalence and Clinical Impact of Atrial Fibrillation in Elderly Patients With Cryptogenic Stroke and High-Risk Patent Foramen Ovale

Evaluation of Prevalence and Clinical Impact of Atrial Fibrillation in Elderly Patients With Cryptogenic Stroke and High-Risk Patent Foramen Ovale

Recruiting
60 years and older
All
Phase N/A

Overview

The purpose of DEFENSE-ELDERLY is to identify the prevalence of AF and evaluate the clinical impact of AF in elderly ESUS patients and no other known sources of stroke besides a high-risk patent foramen ovale, and compare it with elderly ESUS patients without high-risk PFO (no PFO or non-high risk PFOs)

Description

The purpose of DEFENSE-ELDERLY is to identify the prevalence of AF and evaluate the clinical impact of AF in elderly ESUS patients and no other known sources of stroke besides a high-risk patent foramen ovale, and compare it with elderly ESUS patients without high-risk PFO (no PFO or non-high risk PFOs)

Eligibility

Inclusion Criteria:

  • Patients 60 y/o with ESUS and PFO that is likely to have causative role (high-risk anatomical feature) (cohort A)
  • Patients 60 y/o with ESUS without PFO, or with non-high risk PFO (cohort B)
  • The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the institutional review board
  • Patients who are scheduled to have implantable cardiac monitoring

Exclusion Criteria:

  • Transient ischemic attack
  • Lacunar infarction (infarction at subcortical area with a lesion diameter less than 2cm on MR)
  • Presence of complex aortic atheroma (4mm in plaque thickness or presence of mobile components)
  • Presence of 50% luminal stenosis (extra- or intracranial) in arteries supplying the ischemic area
  • Unwillingness or inability to comply with the procedures described in this protocol
  • Life expectancy < 1 years for any non-cardiac or cardiac causes

Study details
    Cryptogenic Stroke
    High Risk Patent Foramen Ovale

NCT04285918

Asan Medical Center

16 February 2024

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