Cryptogenic Stroke, High Risk Patent Foramen Ovale
Conditions
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 foramen ovale, and compare it with elderly ESUS patients without high-risk PFO (no PFO or non-high risk PFOs)
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 foramen ovale, and compare it with elderly ESUS patients without high-risk PFO (no PFO or non-high risk PFOs)
Interventions
PROCEDUREPercutaneous 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.
Sponsors
Medtronic
Asan Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Paroxysmal AF episodes > 30 seconds detected with intermittent recordings or ≥ 2 minutes during ICM within 6 months | Enrollment to 6 months | Paroxysmal AF episodes \> 30 seconds detected with intermittent recordings or ≥ 2 minutes during ICM within 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 ≥ 2 minutes during ICM within 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 | Paroxysmal AF episodes \> 30 seconds detected with intermittent recordings or ≥ 6 minutes during ICM at 6 months and 36 months |
| Rates of percutaneous device closure, prescription of anticoagulants (warfarin or direct oral anticoagulants) | Enrollment to 36 months | Rates of percutaneous device closure, prescription of anticoagulants (warfarin or direct oral anticoagulants) |
| Recurrent stroke or TIA | Enrollment to 36 months | Recurrent stroke or TIA |
| All-cause death, Vascular Death | Enrollment to 36 months | All-cause death, Vascular Death |
Countries
South Korea
Contacts
Primary ContactJae-Kwan Song
Backup ContactJong S Kim
Outcome results
None listed