Evaluation of Prevalence and Clinical Impact of Atrial Fibrillation in Elderly Patients With Cryptogenic Stroke and High-Risk Patent Foramen Ovale
NCT ID: NCT04285918
Last Updated: 2020-02-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
300 participants
OBSERVATIONAL
2019-10-02
2024-10-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cohort A
Patients ≥60 y/o with ESUS and PFO that is likely to have causative role (high-risk anatomical feature)
Percutaneous device closure
If there is no relevant AF detected for 6 months during intermittent follow-up or ICM, device closure of PFO is recommended for high-risk PFOs but is decided ultimately at the discretion of the attending physician. If there is any relevant AF identified from ICM or other modalities during follow-up, adequate secondary prevention with anticoagulants should be carried out. All this process and decision making should be a part of routine clinical practice.
Cohort B
Patients ≥60 y/o with ESUS without PFO, or with non-high risk PFO
No interventions assigned to this group
Interventions
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Percutaneous device closure
If there is no relevant AF detected for 6 months during intermittent follow-up or ICM, device closure of PFO is recommended for high-risk PFOs but is decided ultimately at the discretion of the attending physician. If there is any relevant AF identified from ICM or other modalities during follow-up, adequate secondary prevention with anticoagulants should be carried out. All this process and decision making should be a part of routine clinical practice.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
60 Years
ALL
No
Sponsors
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Medtronic
INDUSTRY
Asan Medical Center
OTHER
Responsible Party
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Jae-Kwan Song
Jae-Kwan Song
Locations
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Asan Medical Center
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2019-1112
Identifier Type: -
Identifier Source: org_study_id
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