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Wearable ECG for AF Screening and Stroke Risk Assessment

NCT06907264 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 243

Last updated 2025-04-02

No results posted yet for this study

Summary

This study aims to evaluate the application of wearable ECG garments in atrial fibrillation (AF) screening and stroke risk assessment. Using a prospective, multicenter, observational design, the study will recruit high-risk stroke patients aged 40 and above to undergo 24-hour continuous ECG monitoring with wearable ECG garments. The study will assess the detection rate of AF and explore the correlation between heart rate variability (HRV) parameters and stroke risk. Additionally, the study will analyze the association between P-wave indices and AF, and evaluate the acceptability of the device among patients and healthcare providers. The primary goal is to validate the accuracy of wearable ECG garments in AF detection and explore their predictive value for stroke risk in high-risk populations.

Conditions

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.

Sponsors & Collaborators

  • Beijing Pinggu District Hospital

    collaborator OTHER

  • Beijing Tsinghua Chang Gung Hospital

    lead OTHER

Principal Investigators

  • Jian Wu, MD. · BeijingTsinghua Changgung Hospital, School of Clinical Medicine,Tsinghua Medicine, Tsinghua University

  • Yating Wu, MD. · BeijingTsinghua Changgung Hospital, School of Clinical Medicine,Tsinghua Medicine, Tsinghua University

  • Yifei Chen, MD. · Pinggu District Hospital

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-04-01
Primary Completion
2026-12-31
Completion
2027-12-31

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06907264 on ClinicalTrials.gov