RecruitingNCT05238610

Prospective Registry of Elderly ESUS With PFO

Prospective Registry of Elderly Patients With ESUS to Evaluate the Role of Covert Atrial Fibrillation and Patent Foramen Ovale


Sponsor

Asan Medical Center

Enrollment

1,200 participants

Start Date

Jan 17, 2022

Study Type

OBSERVATIONAL

Conditions

Summary

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


Eligibility

Min Age: 60 Years

Inclusion Criteria4

  • Patients older than 60 years-old
  • Patients diagnosed as ESUS within 180 days from onset
  • PFO found from TTE or TEE, which attributed to the ischemic stroke
  • Patients or their legal representative agreed to participate

Exclusion Criteria9

  • Patients with transient ischemic attack
  • Patients with ischemic stroke at the vascular territory with significant stenosis
  • Patients with high risk cardioembolic stroke detected from EKG, Holter monitoring or echocardiography
  • Patients with other causes which may cause stroke (i.e. vasculitis, dissection, vasospasm, drug related or Moyamoya disease)
  • Patients with active cancer
  • Patients who need long term anticoagulation
  • Patients who have side effect on antiplatelet treatment
  • Patients with active internal bleeding
  • Patients who refuse to participate

Interventions

PROCEDUREPFO closure

PFO-closure will be performed after 3-6 month of observation and monitoring for paroxysmal atrial fibrillation


Locations(1)

Asan Medical Center

Seoul, South Korea

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NCT05238610


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