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

Recruiting

• Conditions: High Risk Patent Foramen Ovale; Cryptogenic Stroke
• Interventions: Procedure: Percutaneous device closure

• Registration Number: NCT04285918
• Lead Sponsor: Asan Medical Center

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)

Study Timeline

• Study Start: 2019-10-02
• Status Verified: 2020-02
• Study First Submitted: 2020-02-25
• Study First Submitted QC: 2020-02-25
• Last Update Submitted: 2020-02-25
• Study First Posted: 2020-02-26
• Last Update Posted: 2020-02-26
• Primary Completion: 2024-10-02
• Study Completion: 2024-10-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort A	Percutaneous device closure	Patients ≥60 y/o with ESUS and PFO that is likely to have causative role (high-risk anatomical feature)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of