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

Asan Medical Center

Status

Enrolling

Conditions

Cryptogenic Stroke

High Risk Patent Foramen Ovale

Treatments

Procedure: Percutaneous device closure

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT04285918

2019-1112

Details and patient eligibility

About

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)

Full description

Enrollment

300 estimated patients

Sex

All

Ages

60+ years old

Volunteers

No Healthy Volunteers

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