Guidance
Evidence-based recommendations on lead-I electrocardiogram (ECG) devices (imPulse, Kardia Mobile, MyDiagnostick and Zenicor-ECG) for detecting symptomatic atrial fibrillation using single time point testing in primary care.
This guidance covers devices that are used to record and analyse a single time point lead-I ECG for people in primary care with symptoms of atrial fibrillation and an irregular pulse. Using the devices for taking ECGs other than a single time point lead-I ECG reading, or for screening for atrial fibrillation in people without symptoms, was outside the scope of the assessment.
NICE is aware that there are wearable devices for detecting irregular heart rhythms available on the market. These devices are consumer devices and are not intended for use by healthcare professionals in diagnosing atrial fibrillation. It is expected that healthcare professionals would use clinical judgement and provide standard care following clinical guidelines when investigating an irregular heart rhythm and a potential diagnosis of atrial fibrillation. Findings from a consumer wearable device are one of many factors which may lead a patient to seek an appointment with a healthcare professional.
NICE has also published a medtech innovation briefing on Kardia Mobile for detecting atrial fibrillation.
One of the 5 lead-I ECG devices in the scope, the RhythmPad GP (Cardiocity Ltd), was removed from this guidance after consultation. This was because the company informed NICE that, following a change in the CE mark, the device is no longer intended for detecting atrial fibrillation in people with signs or symptoms using single time point testing in primary care.
Is this guidance up to date?
Next review: 2022