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

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 Overview

• Status: Recruiting
• Conditions: Cryptogenic Stroke; High Risk Patent Foramen Ovale
• Intervention / Treatment: Procedure: Percutaneous device closure

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 Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Jae-Kwan Song; Phone Number: +82 2 3010 3155; Email: jksong@amc.seoul.kr
• Study Contact Backup: Name: Jong S Kim; Phone Number: +82 2 3010 3442; Email: jongskim@amc.seoul.kr

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Asan Medical Center
    • Contact: Jae-Kwan Song; Phone Number: +82 3 3010 3155; Email: jksong@amc.seoul.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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)

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort A; Patients ≥60 y/o with ESUS and PFO that is likely to have causative role (high-risk anatomical feature)	Procedure: Percutaneous 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.
Cohort B; Patients ≥60 y/o with ESUS without PFO, or with non-high risk PFO

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Asan Medical Center
• Collaborators: Medtronic

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2019
• Primary Completion (Anticipated): October 2, 2024
• Study Completion (Anticipated): October 2, 2024

Study Registration Dates

• First Submitted: February 25, 2020
• First Submitted That Met QC Criteria: February 25, 2020
• First Posted (Actual): February 26, 2020

Study Record Updates

• Last Update Posted (Actual): February 26, 2020
• Last Update Submitted That Met QC Criteria: February 25, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Congenital Abnormalities; Arrhythmias, Cardiac; Heart Defects, Congenital; Cardiovascular Abnormalities; Heart Septal Defects, Atrial; Heart Septal Defects; Stroke; Ischemic Stroke; Atrial Fibrillation; Foramen Ovale, Patent
• Other Study ID Numbers: 2019-1112

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No