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

Plain Language Summary

Simplified for easier understanding

This registry study tracks older patients who had a stroke of unknown cause (called ESUS — embolic stroke of undetermined source) and were found to have a small hole in the heart (patent foramen ovale, or PFO). Researchers want to understand the best way to prevent future strokes in this group. **You may be eligible if...** - You are over 60 years old - You were diagnosed with ESUS (a specific type of unexplained ischemic stroke) within the past 180 days - A hole in your heart (PFO) was found on echocardiogram and is thought to be related to the stroke **You may NOT be eligible if...** - Your stroke was a transient ischemic attack (TIA) only - A clear cause for your stroke was found (e.g., a clot from the heart or a blocked artery) - You have active cancer - You need long-term blood thinners or have had side effects from antiplatelet medications - You have active internal bleeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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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