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

NCT04285918 | Unknown

• 1 other identifier: 2019-1112
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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)

Conditions

Cryptogenic Stroke; High Risk Patent Foramen Ovale

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

  6 months to 36 months

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

  Enrollment to 36 months

• Recurrent stroke or TIA

  Enrollment to 36 months

• All-cause death, Vascular Death

  Enrollment to 36 months

Study Arms (2)

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

Cohort B

Patients ≥60 y/o with ESUS without PFO, or with non-high risk PFO

Interventions

Percutaneous device closure PROCEDURE

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 A

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Asan Medical Center: lead
• Medtronic: collaborator

Study Sites (1)

Asan Medical Center

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study 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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Jae-Kwan Song

Study Record Dates

• First Submitted: February 25, 2020
• First Posted: February 26, 2020
• Study Start: October 2, 2019
• Primary Completion: October 2, 2024
• Study Completion: October 2, 2024
• Last Updated: February 26, 2020

Record last verified: 2020-02

Locations

KR (1)