Status:
UNKNOWN
Evaluation of Prevalence and Clinical Impact of Atrial Fibrillation in Elderly Patients With Cryptogenic Stroke and High-Risk Patent Foramen Ovale
Lead Sponsor:
Asan Medical Center
Collaborating Sponsors:
Medtronic
Conditions:
Cryptogenic Stroke
High Risk Patent Foramen Ovale
Eligibility:
All Genders
60+ years
Brief Summary
The purpose of DEFENSE-ELDERLY is to identify the prevalence of AF and evaluate the clinical impact of AF in elderly ESUS patients and no other known sources of stroke besides a high-risk patent foram...
Detailed Description
The purpose of DEFENSE-ELDERLY is to identify the prevalence of AF and evaluate the clinical impact of AF in elderly ESUS patients and no other known sources of stroke besides a high-risk patent foram...
Eligibility Criteria
Inclusion
- Patients ≥60 y/o with ESUS and PFO that is likely to have causative role (high-risk anatomical feature) (cohort A)
- Patients ≥60 y/o with ESUS without PFO, or with non-high risk PFO (cohort B)
- The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the institutional review board
- Patients who are scheduled to have implantable cardiac monitoring
Exclusion
- Transient ischemic attack
- Lacunar infarction (infarction at subcortical area with a lesion diameter less than 2cm on MR)
- Presence of complex aortic atheroma (≥4mm in plaque thickness or presence of mobile components)
- Presence of ≥50% luminal stenosis (extra- or intracranial) in arteries supplying the ischemic area
- Unwillingness or inability to comply with the procedures described in this protocol
- Life expectancy \< 1 years for any non-cardiac or cardiac causes
Key Trial Info
Start Date :
October 2 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 2 2024
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT04285918
Start Date
October 2 2019
End Date
October 2 2024
Last Update
February 26 2020
Active Locations (1)
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1
Asan Medical Center
Seoul, South Korea