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TERMINATED
NCT04624646
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Clinical Implication of Atrial Fibrillation Detection Using Wearable Device in Patients With Cryptogenic Stroke

Sponsor: Ewha Womans University Mokdong Hospital

View on ClinicalTrials.gov

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. 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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

338

Start Date

2020-11-17

Completion Date

2026-07-08

Last Updated

2026-09-30

Healthy Volunteers

No

Interventions

DEVICE

Ambulatory Holter monitoring

At least one 24- to 72-hour ambulatory Holter recording; additional monitoring at the physician's discretion.

DEVICE

Discontinuous monitoring

Twice-daily 30-second handheld single-lead ECG recording for 12 months.

DEVICE

Continuous single-lead ECG Patch

72-hour continuous single-lead patch ECG monitoring at 1, 3, 6, and 12 months (four sessions)

Locations (7)

Ewha Womans University Seoul Hospital

Gangseo, Seoul, South Korea

Hanyang University Seoul Hospital

Seongdong, Seoul, South Korea

Korea University Guro Hospital

Seoul, Seoul, South Korea

Ewha Womans University Mokdong Hospital

Yangcheon, Seoul, South Korea

Daegu Catholic University Medical Center

Daegu, South Korea

Kyung Hee University Hospital

Seoul, South Korea

Yonsei University Health System, Severance Hospital

Seoul, South Korea