Diagnostic Accuracy of WEARable TECHnology Single-lead ECG in Detecting Cardiac Arrhythmias
| 대상 질환 | Cardiac Arrhythmia, Atrial Fibrillation |
|---|---|
| 임상 단계 | 단계 해당 없음 |
| 스폰서 | Oxford University Hospitals NHS Trust |
| 상태 | 완료 |
| 참여자 수 | 500 명 |
| 중재(약물) | Group A, Group B |
| 시작일 | 2022년 4월 18일 |
| 완료일 | 2023년 4월 1일 |
| 결과 공개일 | 2026년 6월 1일 |
요약
Atrial fibrillation (AF) is the most common arrhythmia (irregular heart rhythm), affecting 1-2 million people in the UK. AF significantly increases the risk of an AF-related stroke, heart failure and dementia. A significant proportion of people will have no symptoms, and they may only be found to have AF after suffering an AF-related stroke. An electrocardiogram (ECG) uses sensors placed on the skin to record the heart's electrical activity. A 12-lead ECG uses 10 sensors and is the gold-standard (best available test) to detect any abnormal heart rhythm disturbances. Until recently, a 12-lead ECG showing an irregular heart rhythm was required to make a diagnosis of AF but as AF episodes are often short and unpredictable it may be missed. Therefore, a small device that continuously records heartbeat and heart rhythm could make the diagnosis of arrhythmias and AF much quicker and easier. Accessories such as watches or rings - referred to as wearable devices - have extremely good sensors that measure pulse rate by detecting small changes in skin colour during each heartbeat and can perform a single-lead ECG. Algorithms built in the wearable devices can identify irregular heart rhythms,
Compare the Diagnostic Performance of Physician Rhythm Interpretation of 1-lead ECG Generated by SkyLabs CART-I Ring and Apple Watch Versus 12-lead ECG (Gold-standard) for Atrial Fibrillation
| Apple Watch | 95.4 Percentage of cases |
|---|---|
| CART Ring | 94.3 Percentage of cases |
| Apple Watch | 89.8 Percentage of cases |
| CART Ring | 88.8 Percentage of cases |
| Apple Watch | 85.6 Percentage of cases |
| CART Ring | 84.3 Percentage of cases |
BENITIONS에서 보기 ClinicalTrials.gov 원문 보기
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