Cryptogenic StrokeDefenseElderlyNCT04285918
Evaluation of Prevalence and Clinical Impact of Atrial Fibrillation in Elderly Patients With Cryptogenic Stroke and High-Risk Patent Foramen Ovale
An observational study of Cryptogenic Stroke and High Risk Patent Foramen Ovale, run by Asan Medical Center at 1 site in South Korea.
Trial 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) Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Cryptogenic Stroke, High Risk Patent Foramen Ovale
- What is being tested?
- Percutaneous device closure
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Oct 2019to 2 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Asan Medical Center
Seoul
Jae-Kwan Song, +82 3 3010 3155, jksong@amc.seoul.kr
About this study
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)
Read the 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)
- Conditions
- Cryptogenic Stroke, High Risk Patent Foramen Ovale
- Being tested
- Percutaneous device closure
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous device closureProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Patients ≥60 y/o with ESUS and PFO that is likely to have causative role (high-risk anatomical feature) Receives: Procedure: Percutaneous device closure | |
| Cohort B | Patients ≥60 y/o with ESUS without PFO, or with non-high risk PFO |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Enrollment to 6 months
Secondary outcomes (5)
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
Measured: 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
Measured: 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)
Measured: Enrollment to 36 months
Recurrent stroke or TIA
Recurrent stroke or TIA
Measured: Enrollment to 36 months
All-cause death, Vascular Death
All-cause death, Vascular Death
Measured: Enrollment to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2020
- Study start2 Oct 2019
- Primary completion2 Oct 2024 (estimated)
- Study completion2 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cryptogenic StrokeStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Principal investigator, Jae-Kwan Song, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04285918
- Sponsor's protocol ID
- 2019-1112
- Acronym
- DefenseElderly
- Status last verified
- Feb 2020
- First submitted
- 25 Feb 2020
- Last updated
- 26 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Prevalence and Clinical Impact of Atrial Fibrillation in Elderly Patients With Cryptogenic Stroke and High-Risk Patent Foramen Ovale
- ClinicalTrials.gov ID
- NCT04285918
- Acronym / sponsor ID
- DefenseElderly / 2019-1112
- Conditions
- Cryptogenic Stroke, High Risk Patent Foramen Ovale
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 2 Oct 2019 (actual)
- Primary completion
- 2 Oct 2024 (estimated)
- Study completion
- 2 Oct 2024 (estimated)
- First posted
- 26 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A | – | Procedure: Percutaneous device closurePatients ≥60 y/o with ESUS and PFO that is likely to have causative role (high-risk anatomical feature) |
| Cohort B | – | –Patients ≥60 y/o with ESUS without PFO, or with non-high risk PFO |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous device closureIf 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. | Procedure or surgery | Cohort A |
Primary outcome
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
5 secondary outcomes
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Cryptogenic Stroke
Recruiting
Discontinuation of Antithrombotic Treatment Following Patent Foramen Ovale Closure in Young Patients With Cryptogenic Stroke
Patent Foramen Ovale, Ischemic Stroke
Not yet recruiting
CATCH AF - Atrial Fibrillation Detection in Cryptogenic Stroke
Atrial Fibrillation (AF)
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingPhase 4
NeuroAiD Patient-Reported Outcomes in Patients With Mild to Moderate Ischemic Stroke
Stroke, Stroke, Acute Ischemic
Recruiting
Intensive Cancer Screening After Cryptogenic Stroke
Occult Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cryptogenic Stroke and High Risk Patent Foramen Ovale, run by Asan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jae-Kwan Song (+82 2 3010 3155, jksong@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Paroxysmal AF episodes > 30 seconds detected with intermittent recordings or ≥ 2 minutes during ICM within 6 months (time frame: Enrollment to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2020.