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NCT05238610Recruiting

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

Source: ClinicalTrials.gov · Last updated 14 Feb 2022 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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

Status (registry)
Recruiting
Study type
Observational
Enrollment
1200 (estimated)
First submitted
2 Feb 2022
Start date
17 Jan 2022
Primary completion date
31 May 2026
Lead sponsor
Asan Medical Center
NCT number
NCT05238610

What you commit to

  • Study type: Observational
  • Planned participants: 1200
  • From 17 Jan 2022 to the primary completion date, 31 May 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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 with active internal bleeding

Other

  • Patients with transient ischemic attack
  • Patients who need long term anticoagulation
  • Patients who have side effect on antiplatelet treatment
  • Patients who refuse to participate

Who the study is looking for

  • 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

Age in the registry: 60 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Asan Medical Center
Coordinator of this site? Confirm its status
SeoulSouth KoreaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.