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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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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)
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A | Patients ≥60 y/o with ESUS and PFO that is likely to have causative role (high-risk anatomical feature) |
| |
| Cohort B | Patients ≥60 y/o with ESUS without PFO, or with non-high risk PFO |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous device closure | Procedure | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients ≥60 y/o with ESUS and PFO that is likely to have causative role (high-risk anatomical feature) (cohort A) and Patients ≥60 y/o with ESUS without PFO, or with non-high risk PFO (cohort B)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jae-Kwan Song | Contact | +82 2 3010 3155 | jksong@amc.seoul.kr | |
| Jong S Kim | Contact | +82 2 3010 3442 | jongskim@amc.seoul.kr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Recruiting | Seoul | South Korea |
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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 |
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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