NCT04624646Terminated
Clinical Implication of Atrial Fibrillation Detection Using Wearable Device in Patients With Cryptogenic Stroke
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
Source: ClinicalTrials.gov · Last updated 13 Oct 2026
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.
Brief summary (registry, in English)
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.
- Status (registry)
- Terminated
- Study type
- Interventional
- Enrollment
- 338 (actual)
- First submitted
- 5 Nov 2020
- Start date
- 17 Nov 2020
- Primary completion date
- 8 Jul 2026
- Lead sponsor
- Ewha Womans University Mokdong Hospital
- Diseases
- Atrial fibrillation, Stroke
- NCT number
- NCT04624646
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Known or documented atrial fibrillation, including prior atrial fibrillation with restored sinus rhythm
Other illness
- Identified etiology of the stroke or transient ischemic attack
- Pregnancy or lactation - Skin cancer, rash, skin disease, keloid, or injury at the patch site (current or history)
Other
- Pacemaker, implantable cardioverter-defibrillator, or other implanted electrical device
- Unable to use the smartphone-based recorder alone or with the help of others
- Life expectancy less than 1 year
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Daegu Catholic University Medical Center | Daegu | South Korea | Unknown status |
| Ewha Womans University Seoul Hospital | Gangseo | South Korea | Unknown status |
| Hanyang University Seoul Hospital | Seongdong | South Korea | Unknown status |
| Kyung Hee University Hospital | Seoul | South Korea | Unknown status |
| Korea University Guro Hospital | Seoul | South Korea | Unknown status |
| Yonsei University Health System, Severance Hospital | Seoul | South Korea | Unknown status |
| Ewha womans university mokdong hospital | Yangcheon | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.