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

Asan Medical Center300 enrolled

Overview

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)

Study Type

OBSERVATIONAL

Enrollment

300

Conditions

Cryptogenic Stroke High Risk Patent Foramen Ovale

Interventions

Percutaneous device closurePROCEDURE

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

Sex: ALLMin age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

Asan Medical Center

Seoul, South Korea

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: Enrollment to 6 months

Secondary Outcomes

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

Time frame: 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

Time frame: 6 months to 36 months

Rates of percutaneous device closure, prescription of anticoagulants (warfarin or direct oral anticoagulants)

Time frame: Enrollment to 36 months

Recurrent stroke or TIA

Time frame: Enrollment to 36 months

All-cause death, Vascular Death

Time frame: Enrollment to 36 months

Central Contacts

Jae-Kwan Song

CONTACT

+82 2 3010 3155 jksong@amc.seoul.kr

Jong S Kim

CONTACT

+82 2 3010 3442 jongskim@amc.seoul.kr

Data from ClinicalTrials.gov

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