Atrial FibrillationCANDLE-AFNCT04624646
Clinical Implication of Atrial Fibrillation Detection Using Wearable Device in Patients With Cryptogenic Stroke
A study testing Ambulatory Holter monitoring, Discontinuous monitoring and Continuous single-lead ECG Patch in people with Atrial Fibrillation and Ischemic Stroke, run by Ewha Womans University Mokdong Hospital at 7 sites in South Korea.
Trial summary
Atrial fibrillation (AF) detected after ischemic stroke has immediate therapeutic implications, because it prompts a switch from antiplatelet to anticoagulant therapy. The conventional method used to screen for AF in patients whose stroke has no identified cause (cryptogenic stroke) is 24-hour Holter monitoring. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Ischemic Stroke, Transient Ischemic Attack
- What is being tested?
- Ambulatory Holter monitoring, Discontinuous monitoring and Continuous single-lead ECG Patch
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 338 participants
- Where
- 7 sitesSouth Korea
- Study dates
- 17 Nov 2020to 8 Jul 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Ischemic stroke or transient ischemic attack with no identified cause (cryptogenic) after standard etiologic evaluation, admitted to the neurology department of a participating center
- No history of atrial fibrillation and no atrial fibrillation on the admission ECG or on continuous in-hospital telemetry
- Informed of implantable cardiac monitoring according to guidelines and declined it
- Written informed consent
Who cannot join
- Identified etiology of the stroke or transient ischemic attack
- Known or documented atrial fibrillation, including prior atrial fibrillation with restored sinus rhythm
- Pacemaker, implantable cardioverter-defibrillator, or other implanted electrical device
- Unable to use the smartphone-based recorder alone or with the help of others
- Pregnancy or lactation - Skin cancer, rash, skin disease, keloid, or injury at the patch site (current or history)
- Life expectancy less than 1 year
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
South Korea7 sites
Daegu Catholic University Medical Center
Daegu
Ewha Womans University Seoul Hospital
Gangseo, Seoul, 07985
Hanyang University Seoul Hospital
Seongdong, Seoul, 04763
Korea University Guro Hospital
Seoul, Seoul, 08308
Kyung Hee University Hospital
Seoul, 02447
Yonsei University Health System, Severance Hospital
Seoul, 06273
Ewha Womans University Mokdong Hospital
Yangcheon, Seoul, 07985
About this study
Official title: Clinical Implication of Atrial Fibrillation Detection Using Wearable Device in Patients With Cryptogenic Stroke - The Comparison Between Short-term Continuous Patch and Long-term Discontinuous Monitoring
Atrial fibrillation (AF) detected after ischemic stroke has immediate therapeutic implications, because it prompts a switch from antiplatelet to anticoagulant therapy. The conventional method used to screen for AF in patients whose stroke has no identified cause (cryptogenic stroke) is 24-hour Holter monitoring. CANDLE-AF is a multicenter, open-label, randomized trial comparing three noninvasive monitoring strategies over 12 months in patients with cryptogenic ischemic stroke or transient ischemic attack and no known AF: physician-directed standard care (at least one 24- to 72-hour Holter recording), scheduled 72-hour single-lead patch ECG monitoring repeated at 1, 3, 6, and 12 months, and twice-daily 30-second handheld single-lead ECG recording with a smartphone-based device for 12 months. The primary outcome is detection of AF lasting 30 seconds or longer within 12 months.
- Being tested
- Ambulatory Holter monitoring, Discontinuous monitoring, Continuous single-lead ECG Patch
- Keywords
- Atrial fibrillation, Ischemic Stroke, Transient Ischemic Attack
- Medical subject headings
- Atrial Fibrillation, Ischemic Stroke, Ischemic Attack, Transient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ambulatory Holter monitoringDevice
Also called Standard care
At least one 24- to 72-hour ambulatory Holter recording; additional monitoring at the physician's discretion.
Discontinuous monitoringDevice
Also called iECG, Kardiamobile
Twice-daily 30-second handheld single-lead ECG recording for 12 months.
Continuous single-lead ECG PatchDevice
Also called Patch monitoring, Mobicare, mobiCARE-MC100
72-hour continuous single-lead patch ECG monitoring at 1, 3, 6, and 12 months (four sessions)
| Study group | Role | What they receive |
|---|---|---|
| Conventional Holter Monitoring Group | Active comparator | Physician-directed standard care, including at least one 24- to 72-hour Holter recording; further rhythm monitoring during the 12-month follow-up at the treating physician's discretion. Anticoagulation is recommended when AF is detected, at the treating physician's discretion. Receives: Device: Ambulatory Holter monitoring |
| Discontinuous Monitoring Group | Experimental | Standard care plus twice-daily 30-second single-lead ECG recordings with a smartphone-based handheld recorder (KardiaMobile, AliveCor) for 12 months, transmitted through the smartphone application to a cardiac core laboratory. Anticoagulation is recommended when AF is detected, at the treating physician's discretion. Receives: Device: Ambulatory Holter monitoring; Device: Discontinuous monitoring |
| Single-lead Continuous Patch Group | Experimental | Standard care plus continuous 72-hour single-lead adhesive patch ECG monitoring (mobiCARE-MC100, Seers Technology) at 1, 3, 6, and 12 months after enrollment, transmitted to a cardiac core laboratory. Anticoagulation is recommended when AF is detected, at the treating physician's discretion. Receives: Device: Ambulatory Holter monitoring; Device: Continuous single-lead ECG Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of atrial fibrillation lasting 30 seconds or longer
First detection of AF lasting at least 30 seconds on any ECG recording (assigned device, Holter, 12-lead ECG, or clinical recording), confirmed by physician review
Measured: Within 12 months after randomization
Secondary outcomes (5)
Recurrent ischemic stroke or transient ischemic attack
Measured: Within 12 months after randomization
Major adverse cardiovascular and cerebrovascular events (MACCE)
composite of nonfatal stroke, nonfatal myocardial infarction, and cardiovascular death
Measured: Within 12 months after randomization
Initiation of oral anticoagulation following AF detection
Initiation of oral anticoagulation following AF detection
Measured: Within 12 months after randomization
All-cause readmission
Measured: Within 12 months after randomization
All-cause death
All-cause death
Measured: Within 12 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2020
- Study start17 Nov 2020
- Primary completion8 Jul 2026
- Study completion8 Jul 2026
Why it stopped: Enrollment was closed early in July 2025 because of slow recruitment (338 of 600 planned participants; 324 were required for the superiority comparison). The 12-month follow-up period for all randomized participants ended in July 2026.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 338 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ewha Womans University Mokdong Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Korea Health Industry Development Institute, National Research Foundation of Korea, Korea Medical Device Development Fund, AliveCor
- Responsible party
- Sponsor
- Investigators
- Junbeom Park, M.D., PhD., Principal investigator, Ewha Womans University Mokdong HospitalTae-Jin Song, MD, Principal investigator, Ewha Womans University Seoul HospitalDong-Hyeok Kim, MD, Principal investigator, Ewha Womans University Seoul Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04624646
- Sponsor's protocol ID
- CANDLE-AF Trial
- Other IDs
- NRF-2022R1A2C1093352, RS-2020-KD000234, RS-2025-25459963, KCT0005592
- Acronym
- CANDLE-AF
- Status last verified
- Oct 2026
- First submitted
- 5 Nov 2020
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: De-identified individual participant data underlying the published results, a data dictionary defining each field, and the statistical analysis code will be made available to qualified investigators.
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Implication of Atrial Fibrillation Detection Using Wearable Device in Patients With Cryptogenic Stroke - The Comparison Between Short-term Continuous Patch and Long-term Discontinuous Monitoring
- ClinicalTrials.gov ID
- NCT04624646
- Acronym / sponsor ID
- CANDLE-AF / CANDLE-AF Trial
- Keywords
- Atrial fibrillation, Ischemic Stroke, Transient Ischemic Attack
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment was closed early in July 2025 because of slow recruitment (338 of 600 planned participants; 324 were required for the superiority comparison). The 12-month follow-up period for all randomized participants ended in July 2026.
- Enrolment
- 338 participants (actual)
- Lead sponsor
- Ewha Womans University Mokdong HospitalUniversity, hospital or other
- Collaborators
- Korea Health Industry Development Institute, National Research Foundation of Korea, Korea Medical Device Development Fund, AliveCor
- Study start
- 17 Nov 2020 (actual)
- Primary completion
- 8 Jul 2026 (actual)
- Study completion
- 8 Jul 2026 (actual)
- First posted
- 12 Nov 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.
Atrial fibrillation (AF) detected after ischemic stroke has immediate therapeutic implications, because it prompts a switch from antiplatelet to anticoagulant therapy. The conventional method used to screen for AF in patients whose stroke has no identified cause (cryptogenic stroke) is 24-hour Holter monitoring. CANDLE-AF is a multicenter, open-label, randomized trial comparing three noninvasive monitoring strategies over 12 months in patients with cryptogenic ischemic stroke or transient ischemic attack and no known AF: physician-directed standard care (at least one 24- to 72-hour Holter recording), scheduled 72-hour single-lead patch ECG monitoring repeated at 1, 3, 6, and 12 months, and twice-daily 30-second handheld single-lead ECG recording with a smartphone-based device for 12 months. The primary outcome is detection of AF lasting 30 seconds or longer within 12 months.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conventional Holter Monitoring Group | Active comparator | Device: Ambulatory Holter monitoringPhysician-directed standard care, including at least one 24- to 72-hour Holter recording; further rhythm monitoring during the 12-month follow-up at the treating physician's discretion. Anticoagulation is recommended when AF is detected, at the treating physician's discretion. |
| Discontinuous Monitoring Group | Experimental | Device: Ambulatory Holter monitoring, Device: Discontinuous monitoringStandard care plus twice-daily 30-second single-lead ECG recordings with a smartphone-based handheld recorder (KardiaMobile, AliveCor) for 12 months, transmitted through the smartphone application to a cardiac core laboratory. Anticoagulation is recommended when AF is detected, at the treating physician's discretion. |
| Single-lead Continuous Patch Group | Experimental | Device: Ambulatory Holter monitoring, Device: Continuous single-lead ECG PatchStandard care plus continuous 72-hour single-lead adhesive patch ECG monitoring (mobiCARE-MC100, Seers Technology) at 1, 3, 6, and 12 months after enrollment, transmitted to a cardiac core laboratory. Anticoagulation is recommended when AF is detected, at the treating physician's discretion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 years or older
- Ischemic stroke or transient ischemic attack with no identified cause (cryptogenic) after standard etiologic evaluation, admitted to the neurology department of a participating center
- No history of atrial fibrillation and no atrial fibrillation on the admission ECG or on continuous in-hospital telemetry
- Informed of implantable cardiac monitoring according to guidelines and declined it
- Written informed consent
Key exclusion criteria (6 listed)
- Identified etiology of the stroke or transient ischemic attack
- Known or documented atrial fibrillation, including prior atrial fibrillation with restored sinus rhythm
- Pacemaker, implantable cardioverter-defibrillator, or other implanted electrical device
- Unable to use the smartphone-based recorder alone or with the help of others
- Pregnancy or lactation - Skin cancer, rash, skin disease, keloid, or injury at the patch site (current or history)
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 |
|---|---|---|
| Ambulatory Holter monitoringAlso: Standard careAt least one 24- to 72-hour ambulatory Holter recording; additional monitoring at the physician's discretion. | Device | Conventional Holter Monitoring Group, Discontinuous Monitoring Group, Single-lead Continuous Patch Group |
| Discontinuous monitoringAlso: iECG, KardiamobileTwice-daily 30-second handheld single-lead ECG recording for 12 months. | Device | Discontinuous Monitoring Group |
| Continuous single-lead ECG PatchAlso: Patch monitoring, Mobicare, mobiCARE-MC10072-hour continuous single-lead patch ECG monitoring at 1, 3, 6, and 12 months (four sessions) | Device | Single-lead Continuous Patch Group |
Primary outcome
Detection of atrial fibrillation lasting 30 seconds or longer
Time frame: Within 12 months after randomization
First detection of AF lasting at least 30 seconds on any ECG recording (assigned device, Holter, 12-lead ECG, or clinical recording), confirmed by physician review
5 secondary outcomes
Recurrent ischemic stroke or transient ischemic attack
Time frame: Within 12 months after randomization
Major adverse cardiovascular and cerebrovascular events (MACCE)
Time frame: Within 12 months after randomization
Initiation of oral anticoagulation following AF detection
Time frame: Within 12 months after randomization
All-cause readmission
Time frame: Within 12 months after randomization
All-cause death
Time frame: Within 12 months after randomization
Results and safety
The study was stopped early (reason given: Enrollment was closed early in July 2025 because of slow recruitment (338 of 600 planned participants; 324 were required for the superiority comparison). The 12-month follow-up period for all randomized participants ended in July 2026.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the published results, a data dictionary defining each field, and the statistical analysis code will be made available to qualified investigators.
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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.
Junbeom Park, M.D., PhD. principal investigator
Ewha Womans University Mokdong Hospital
Tae-Jin Song, MD principal investigator
Ewha Womans University Seoul Hospital
Dong-Hyeok Kim, MD principal investigator
Ewha Womans University Seoul Hospital
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ambulatory Holter monitoring, Discontinuous monitoring and Continuous single-lead ECG Patch in people with Atrial Fibrillation and Ischemic Stroke, run by Ewha Womans University Mokdong Hospital at 7 sites 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 5 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: stopped early, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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 was stopped early (reason given: Enrollment was closed early in July 2025 because of slow recruitment (338 of 600 planned participants; 324 were required for the superiority comparison). The 12-month follow-up period for all randomized participants ended in July 2026.). Results are not available in the source record.
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?
Detection of atrial fibrillation lasting 30 seconds or longer (time frame: Within 12 months after randomization). 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 13 Oct 2026.