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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04285918
Recruitment Status : Recruiting
First Posted : February 26, 2020
Last Update Posted : February 26, 2020
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Jae-Kwan Song, 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)

Condition or disease Intervention/treatment
Cryptogenic Stroke High Risk Patent Foramen Ovale 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)

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Prevalence and Clinical Impact of Atrial Fibrillation in Elderly Patients With Cryptogenic Stroke and High-Risk Patent Foramen Ovale
Actual Study Start Date : October 2, 2019
Estimated Primary Completion Date : October 2, 2024
Estimated Study Completion Date : October 2, 2024

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Paroxysmal AF episodes > 30 seconds detected with intermittent recordings or ≥ 2 minutes during ICM within 6 months [ Time Frame: Enrollment to 6 months ]
    Paroxysmal AF episodes > 30 seconds detected with intermittent recordings or ≥ 2 minutes during ICM within 6 months


Secondary Outcome Measures :
  1. 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 ≥ 2 minutes during ICM within 36 months

  2. 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 ]
    Paroxysmal AF episodes > 30 seconds detected with intermittent recordings or ≥ 6 minutes during ICM at 6 months and 36 months

  3. Rates of percutaneous device closure, prescription of anticoagulants (warfarin or direct oral anticoagulants) [ Time Frame: Enrollment to 36 months ]
    Rates of percutaneous device closure, prescription of anticoagulants (warfarin or direct oral anticoagulants)

  4. Recurrent stroke or TIA [ Time Frame: Enrollment to 36 months ]
    Recurrent stroke or TIA

  5. All-cause death, Vascular Death [ Time Frame: Enrollment to 36 months ]
    All-cause death, Vascular Death



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04285918


Contacts
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Contact: Jae-Kwan Song +82 2 3010 3155 jksong@amc.seoul.kr
Contact: Jong S Kim +82 2 3010 3442 jongskim@amc.seoul.kr

Locations
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Korea, Republic of
Asan Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Jae-Kwan Song    +82 3 3010 3155    jksong@amc.seoul.kr   
Sponsors and Collaborators
Asan Medical Center
Medtronic

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Responsible Party: Jae-Kwan Song, Asan Medical Center
ClinicalTrials.gov Identifier: NCT04285918    
Other Study ID Numbers: 2019-1112
First Posted: February 26, 2020    Key Record Dates
Last Update Posted: February 26, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Atrial Fibrillation
Foramen Ovale, Patent
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Heart Diseases
Pathologic Processes
Heart Septal Defects, Atrial
Heart Septal Defects
Heart Defects, Congenital
Cardiovascular Abnormalities
Congenital Abnormalities