Wearable ECG for AF Screening and Stroke Risk Assessment

Not yet recruitingOBSERVATIONAL
Enrollment

243

Participants

Timeline

Start Date

April 1, 2025

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2027

Conditions
Atrial FibrillationStroke
Interventions
DEVICE

Wearable ECG Garment for Continuous Atrial Fibrillation Screening and Stroke Risk Assessment

This intervention utilizes a wearable ECG garment, a non-invasive, textile-based device for continuous 24-hour ECG monitoring. The garment features embedded electrodes to capture heart rate, rhythm, HRV parameters (e.g., SDNN, RMSSD, LF/HF), and P-wave indices (e.g., P-wave duration, PtfV1), enabling comprehensive assessment of atrial fibrillation (AF) and stroke risk. The device is lightweight, comfortable, and supports wireless data transmission to the cloud for real-time analysis. The study incorporates machine learning algorithms to identify AF patterns and explore stroke risk predictors, targeting individuals aged 40+ at high stroke risk. It also evaluates device acceptability and usability, aiming to improve AF detection rates, enable early intervention, and reduce stroke risk.

Trial Locations (2)

101200

Pinggu District Hospital, Beijing

102218

Beijing Tsinghua Changgung Hospital, Beijing

All Listed Sponsors
collaborator

Beijing Pinggu District Hospital

OTHER

lead

Beijing Tsinghua Chang Gung Hospital

OTHER

NCT06907264 - Wearable ECG for AF Screening and Stroke Risk Assessment | Biotech Hunter | Biotech Hunter