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Prospective Registry of Elderly ESUS With PFO

Recruitingn/aAges 60 Years - anyAllAsan Medical Center
NCT05238610 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Patent foramen ovale (PFO) is associated with an increased risk of stroke. PFO-closure was effective in preventing stroke in young stroke patients less than age 60 presented as an embolic stroke of undetermined source (ESUS). However, the benefit of PFO-closure in elderly ESUS patients is not clear. The investigators designed this prospective register-based observational study to verify the efficacy of PFO-closure in elderly ESUS patients with high-risk PFO, older than 60 years

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Patients older than 60 years-old 2. Patients diagnosed as ESUS within 180 days from onset 3. PFO found from TTE or TEE, which attributed to the ischemic stroke 4. Patients or their legal representative agreed to participate Exclusion Criteria: 1. Patients with transient ischemic attack 2. Patients with ischemic stroke at the vascular territory with significant stenosis 3. Patients with high risk cardioembolic stroke detected from EKG, Holter monitoring or echocardiography 4. Patients with other causes which may cause stroke (i.e. vasculitis, dissection, vasospasm, drug related or Moyamoya disease) 5. Patients with active cancer 6. Patients who need long term anticoagulation 7. Patients who have side effect on antiplatelet treatment 8. Patients with active internal bleeding 9. Patients who refuse to participate
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What it tests

  • PFO closure
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Where

1 site
Asan Medical Center
Seoul, South Korea
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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