Prospective Registry of Elderly ESUS With PFO
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age60+
SponsorAsan Medical Center
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- PFO closure
Treatment groups
1,200 Participants
are divided into 2 treatment groupsSponsors and collaborators
Asan Medical Center
Lead sponsor
National Evidence-Based Healthcare Collaborating Agency
Collaborator
Source ClinicalTrials.gov