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Wearable ECG Garment for Spotting Atrial Fibrillation and Assessing Stroke Risk

Looks at a wearable ECG garment for finding atrial fibrillation in high stroke risk patients.

Plain-language title generated from the registry record
Registry title: Wearable ECG for AF Screening and Stroke Risk Assessment

Key facts

Where
Beijing, ChinaSee the 2 sites

Where in China

  • Beijing Tsinghua Changgung HospitalBeijing, ChinaNo longer taking part
  • Pinggu District HospitalBeijing, ChinaNo longer taking part

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
Beijing Tsinghua Chang Gung Hospital
Trial code
NCT06907264
Record updated
2 April 2025
Original description
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.Read full original descriptionShow less

Application of Wearable ECG Garments in Atrial Fibrillation Screening and Stroke Risk Assessment

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.

Inclusion: Age ≥ 40 years; High-risk stroke population identified by the "8+2" risk score in stroke screening; Ability to operate the device independently or with assistance from family members; Willingness to participate in the study and provide signed informed consent.

Exclusion: Patients with severe diseases that limit device wear (e.g., advanced malignant tumors, severe infections, Class IV heart failure) or those receiving hospice care; Patients unable to operate the device or understand the study procedures due to cognitive impairment, mental illness, or language communication barriers; Patients who may experience severe discomfort or allergic reactions from wearing the device; Patients already using implanted cardiac monitoring devices.

ClinicalTrials.gov NCT06907264