NCT06907264Not yet recruiting
Wearable ECG for AF Screening and Stroke Risk Assessment
Application of Wearable ECG Garments in Atrial Fibrillation Screening and Stroke Risk Assessment
Source: ClinicalTrials.gov · Last updated 2 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 243 (estimated)
- First submitted
- 26 Mar 2025
- Start date
- 1 Apr 2025
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Beijing Tsinghua Chang Gung Hospital
- Diseases
- Stroke, Atrial fibrillation
- NCT number
- NCT06907264
What you commit to
- Study type: Observational
- Planned participants: 243
- From 1 Apr 2025 to the primary completion date, 31 Dec 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with severe diseases that limit device wear (e.g., advanced malignant tumors, severe infections, Class IV heart failure) or those receiving hospice care.
Other illness
- 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.
Who the study is looking for
- 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.
Age in the registry: 40 years to - · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Tsinghua Changgung Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Pinggu District Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.