Embolic Stroke of Undetermined SourceNCT05431972
Cardea SOLOTM for Paroxysmal Atrial Fibrillation Diagnosis in ESUS Patients With Left Atrial Enlargement
A study testing Cardea SOLO and 12 Lead EKG in people with Embolic Stroke of Undetermined Source, run by Asan Medical Center at 1 site in South Korea.
Trial summary
The aim of the study is to evaluate the efficacy and safety of the Cardea SOLO Compared to 12 lead EKG for Paroxysmal Atrial Fibrillation Diagnosis in ESUS patients with Left Atrial Enlargement. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Embolic Stroke of Undetermined Source
- What is being tested?
- Cardea SOLO and 12 Lead EKG
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 257 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Nov 2022to 13 Sep 2024
- Phase
- Interventional
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inclusion NO. 3 or 4 must be satisfied, and No. 2, 5 and 6 must be satisfied.
- 2. On the Screening date, Stroke onset date is not over 60 days.
- 3. ESUS Diagnosis : all of a~e must be satisfied.
- a. Ischemic stroke detected by CT or MRI that is not lacunar
- b. A person without arteriosclerosis which causes at least 50% stenosis of the intracranial/external arteries supplied to the ischemic site
- c. During continuous monitoring or halter monitoring In the stroke intensive care unit, Person without atrial fibrillation and persistent atrial fibrillation
Show all 11Show fewer
- d. When checked the Transthoracic echocardiography, No major risk cardioembolic source of embolism. (ex. Myocardial infarction within 4 weeks, mitral stenosis, artificial heart valve and so on)
- e. NO other specific cause of stroke identified(et, arteritis, dissection and drug abuse)
- 4. cardioembolism is classified by TOAST classification.
- 5. Left ventricle Enlargement(male >40mm, female >38mm, LAVI >35ml/m2
- 6. Voluntarily sign the consent form
Who cannot join
- Transient cerebral ischemic attack
- Active cancer
- Heart embolism, stroke of major heart embolism, stroke high-risk disease
- Left atrial thrombus
- Left ventricular thrombus
- Sick sinus syndrome
Show all 24Show fewer
- Myocardiac infarction in 1 month
- Rheumatic left atrioventricular valve or aortic valve disease
- Artificial heart valve
- Myocardiac infarction (EF<28%)
- Congestive heart failure (EF<30%)
- Dilated cardiomyopathy
- Nonbacterial thrombotic endocarditis
- Endocarditis
- Intracardiac mass
- Atrial fibrillation
- Restriction for echocardiography (obesity, lung disease etc)
- High risk PFO
- Patch apply difficulty(skin allergy, ulticaria, atopic dermatitis, hyperhidrosis)
- Implant cardiac pacemaker
- Life-threatening arrhythmia
- Radiation therapy or MRI scan
- Restriction for Cardia SOLO attachment
- The person who investigator judged unsuitable for the trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Cardea SOLOTM for Paroxysmal Atrial Fibrillation Diagnosis in ESUS Patients With Left Atrial Enlargement: Prospective, Multi-center, Open-label, Randomized, Controlled, Investigator-Initiated Trial
The aim of the study is to evaluate the efficacy and safety of the Cardea SOLO Compared to 12 lead EKG for Paroxysmal Atrial Fibrillation Diagnosis in ESUS patients with Left Atrial Enlargement.
Read the detailed description
The Prospective, Multi-center, Open-label, Randomized, Controlled, Investigator-Initiated Trial will be started on June 2022. Randomized patients in two arms will receive Cardea SOLO or 12 lead EKG respectively. Cardea SOLO received patients will keep it for 7 days. 12 lead EKG received patients will discharge home. After 7 days, Results of Cardea SOLO auto reading will be evaluated by dependent committee including cardiologist.
- Conditions
- Embolic Stroke of Undetermined Source
- Being tested
- Cardea SOLO, 12 Lead EKG
- Keywords
- Embolic stroke of undetermined source, left ventricle enlargement, paroxysmal atrial fibrillation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardea SOLODevice
Neurologist cardiac rhythm translation with 12 lead EKG versus Cardea SOLO
12 Lead EKGDevice
Neurologist cardiac rhythm translation with 12 lead EKG versus Cardea SOLO
| Study group | Role | What they receive |
|---|---|---|
| Cardea SOLO | Experimental | for 7 day holter monitor (patch type) Receives: Device: Cardea SOLO |
| 12 Lead EKG | Active comparator | (traditional EKG for under 2 minutes) Receives: Device: 12 Lead EKG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients number with AF over 30 seconds of cardea SOLO / with AF with 1 time of 12 lead EKG
cardea SOLO and 12 lead EKG is different
Measured: 30 seconds
Secondary outcomes (2)
AF burden(F)
cardea SOLO and 12 lead EKG is different
Measured: 1 week
Number of other dysrhythmia
cardea SOLO and 12 lead EKG is different
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2022
- Study start1 Nov 2022
- Primary completion13 Sep 2024
- Study completion13 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Embolic Stroke of Undetermined SourceStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, Multi-center, Open-label, Randomized, Controlled, Investigator-Initiated Trial
- Masking
- None (open label)
- Enrolment
- 257 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bum Joon Kim, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05431972
- Sponsor's protocol ID
- SOLO-ESUS
- Status last verified
- Dec 2025
- First submitted
- 17 Jun 2022
- Last updated
- 15 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Song K, Song TJ, Woo HG, Kim BJ, Seo WK, Kang HG, Kim CK, Park HK, Jung YH, Choi KH, Kim BJ. Rationale and Design of the Efficacy and Safety of a Patch-Type Cardiac Monitor for Diagnosing Paroxysmal Atrial Fibrillation in Embolic Stroke of Undetermined Source Patients with Left Atrial Enlargement (SOLO-ESUS): A Randomized Controlled Trial. Cerebrovasc Dis. 2026;55(1):83-90. doi: 10.1159/000545883. Epub 2025 Apr 15.
PubMed 40233723
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Cardea SOLOTM for Paroxysmal Atrial Fibrillation Diagnosis in ESUS Patients With Left Atrial Enlargement: Prospective, Multi-center, Open-label, Randomized, Controlled, Investigator-Initiated Trial
- ClinicalTrials.gov ID
- NCT05431972
- Acronym / sponsor ID
- SOLO-ESUS
- Conditions
- Embolic Stroke of Undetermined Source
- Keywords
- Embolic stroke of undetermined source, left ventricle enlargement, paroxysmal atrial fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 257 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 13 Sep 2024 (actual)
- Study completion
- 13 Sep 2024 (actual)
- First posted
- 24 Jun 2022 (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 aim of the study is to evaluate the efficacy and safety of the Cardea SOLO Compared to 12 lead EKG for Paroxysmal Atrial Fibrillation Diagnosis in ESUS patients with Left Atrial Enlargement.
Detailed description
The Prospective, Multi-center, Open-label, Randomized, Controlled, Investigator-Initiated Trial will be started on June 2022. Randomized patients in two arms will receive Cardea SOLO or 12 lead EKG respectively. Cardea SOLO received patients will keep it for 7 days. 12 lead EKG received patients will discharge home. After 7 days, Results of Cardea SOLO auto reading will be evaluated by dependent committee including cardiologist.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, Multi-center, Open-label, Randomized, Controlled, Investigator-Initiated Trial
| Arm | Type | Receives |
|---|---|---|
| Cardea SOLO | Experimental | Device: Cardea SOLOfor 7 day holter monitor (patch type) |
| 12 Lead EKG | Active comparator | Device: 12 Lead EKG(traditional EKG for under 2 minutes) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Inclusion NO. 3 or 4 must be satisfied, and No. 2, 5 and 6 must be satisfied.
- 2. On the Screening date, Stroke onset date is not over 60 days.
- 3. ESUS Diagnosis : all of a~e must be satisfied.
- a. Ischemic stroke detected by CT or MRI that is not lacunar
- b. A person without arteriosclerosis which causes at least 50% stenosis of the intracranial/external arteries supplied to the ischemic site
Key exclusion criteria (24 listed)
- Transient cerebral ischemic attack
- Active cancer
- Heart embolism, stroke of major heart embolism, stroke high-risk disease
- Left atrial thrombus
- Left ventricular thrombus
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 |
|---|---|---|
| Cardea SOLONeurologist cardiac rhythm translation with 12 lead EKG versus Cardea SOLO | Device | Cardea SOLO |
| 12 Lead EKGNeurologist cardiac rhythm translation with 12 lead EKG versus Cardea SOLO | Device | 12 Lead EKG |
Primary outcome
Patients number with AF over 30 seconds of cardea SOLO / with AF with 1 time of 12 lead EKG
Time frame: 30 seconds
cardea SOLO and 12 lead EKG is different
2 secondary outcomes
AF burden(F)
Time frame: 1 week
Number of other dysrhythmia
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
- Derived from this study: PubMed 40233723Song K, Song TJ, Woo HG, Kim BJ, Seo WK, Kang HG, Kim CK, Park HK, Jung YH, Choi KH, Kim BJ. Rationale and Design of the Efficacy and Safety of a Patch-Type Cardiac Monitor for Diagnosing Paroxysmal Atrial Fibrillation in Embolic Stroke of Undetermined Source Patients with Left Atrial Enlargement (SOLO-ESUS): A Randomized Controlled Trial. Cerebrovasc Dis. 2026;55(1):83-90. doi: 10.1159/000545883. Epub 2025 Apr 15.
Related trials for Embolic Stroke of Undetermined Source
Active, not recruitingObservational study
Paroxysmal Nocturnal Hemoglobinuria in ESUS & ETUS
Paroxysmal Nocturnal Hemoglobinuria, Embolic Stroke of Undetermined Source
RecruitingObservational study
SENIOR: Stroke Prevention in the Elderly by Patent Foramen Ovale closuRe vs Anticoagulation
Ischemic Stroke, Embolic Stroke of Undetermined Source
RecruitingObservational study
High Coverage CARotid Stenting vs. Medical Management Alone to Prevent EmboliSm From symptomaTic Non-stenotic cARotid Disease (SyNC)
Carotid Artery Disease, Symptomatic Carotid Artery Stenosis
Recruiting
Atrial Fibrillation Detection Using MEMO Patch in Patients With Stroke of Unknown Cause
Embolic Stroke of Undetermined Source
RecruitingObservational study
AI-Based Prediction of Atrial Fibrillation in ESUS Patients With ICM
Embolic Stroke of Undetermined Source
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardea SOLO and 12 Lead EKG in people with Embolic Stroke of Undetermined Source, 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 11 inclusion and 24 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: finished, as of the sponsor's last update on 15 Dec 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients number with AF over 30 seconds of cardea SOLO / with AF with 1 time of 12 lead EKG (time frame: 30 seconds). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05431972, which also lists 1 linked publication.
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 15 Dec 2025.