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
The COACH-ELDERLY ESUS study is a multicenter, prospective, registry-based, observational study in elderly ESUS patients with high-risk PFO treated with PFO-closure + standard antiplatelet treatment or standard antiplatelet treatment only in 20 centers in Korea. Patients will receive an insertable loop recorder (ILR) to monitor paroxysmal atrial fibrillation. In cases, which are unavailable for ILR, recurrent EKG or Holter monitoring will be done based on the clinician's decision. Based on the attending physicians' decision with a multi-disciplinary approach, patients will receive PFO-closure with standard antiplatelet treatment or standard antiplatelet treatment only.
Study Type
OBSERVATIONAL
Enrollment
1,200
PFO-closure will be performed after 3-6 month of observation and monitoring for paroxysmal atrial fibrillation
Asan Medical Center
Seoul, South Korea
RECRUITINGischemic stroke recurrence
Time to occurrence of ischemic stroke after registration
Time frame: at least 1 year
MACE
Time to major cardiovascular event after registration
Time frame: at least 1 year
Hemorrhagic stroke
Time to hemorrhagic stroke after registration
Time frame: at least 1 year
Vascular death
Time to vascular death after registration
Time frame: at least 1 year
Myocardial infarction
Time to myocardial infarction
Time frame: at least 1 year
Atrial fibrillation after registration
Time to atrial fibrillation after registration
Time frame: at least 1 year
Atrial fibrillation lasting more than 2 or 6 min after registration
Time to atrial fibrillation lasting more than 2 or 6 min after registration
Time frame: at least 1 year
Major bleeding
Time to major bleeding event after registration
Time frame: at least 1 year
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