Evaluation of Prevalence and Clinical Impact of Atrial Fibrillation in Elderly Patients With Cryptogenic Stroke and High-Risk Patent Foramen Ovale

Study Overview
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Brief Summary
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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 foramen ovale, and compare it with elderly ESUS patients without high-risk PFO (no PFO or non-high risk PFOs)

Detailed Description
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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 foramen ovale, and compare it with elderly ESUS patients without high-risk PFO (no PFO or non-high risk PFOs)

Official Title
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Evaluation of Prevalence and Clinical Impact of Atrial Fibrillation in Elderly Patients With Cryptogenic Stroke and High-Risk Patent Foramen Ovale

Conditions
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Cryptogenic Stroke, High Risk Patent Foramen Ovale

Intervention / Treatment
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* Procedure: Percutaneous device closure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort A<br>Patients ≥60 y/o with ESUS and PFO that is likely to have causative role (high-risk anatomical feature) | Procedure: Percutaneous device closure<br>* 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.<br>|
| Cohort B<br>Patients ≥60 y/o with ESUS without PFO, or with non-high risk PFO | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Paroxysmal AF episodes > 30 seconds detected with intermittent recordings or ≥ 2 minutes during ICM within 6 months | Paroxysmal AF episodes > 30 seconds detected with intermittent recordings or ≥ 2 minutes during ICM within 6 months | Enrollment to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Paroxysmal AF episodes > 30 seconds detected with intermittent recordings or ≥ 2 minutes during ICM within 36 months | Paroxysmal AF episodes > 30 seconds detected with intermittent recordings or ≥ 2 minutes during ICM within 36 months | Enrollment to 36 months | 
| Paroxysmal AF episodes > 30 seconds detected with intermittent recordings or ≥ 6 minutes during ICM at 6 months and 36 months | Paroxysmal AF episodes > 30 seconds detected with intermittent recordings or ≥ 6 minutes during ICM at 6 months and 36 months | 6 months to 36 months | 
| Rates of percutaneous device closure, prescription of anticoagulants (warfarin or direct oral anticoagulants) | Rates of percutaneous device closure, prescription of anticoagulants (warfarin or direct oral anticoagulants) | Enrollment to 36 months | 
| Recurrent stroke or TIA | Recurrent stroke or TIA | Enrollment to 36 months | 
| All-cause death, Vascular Death | All-cause death, Vascular Death | Enrollment to 36 months |