Wearable detection of physiological instability in CIED Patients
Research type
Research Study
Full title
Multimodal Characterisation of Short-Term Physiological Instability in Patients with Cardiac Implantable Electronic Devices
IRAS ID
372942
Contact name
Joseph Mayer
Contact email
Sponsor organisation
Interval Labs
Duration of Study in the UK
3 years, 0 months, 2 days
Research summary
Sudden cardiac death and heart failure remain leading causes of morbidity and mortality. Current methods used to predict serious adverse cardiac events rely heavily on static clinical measures such as left ventricular ejection fraction (LVEF), myocardial scar burden, and New York Heart Association (NYHA) class. However, these measures have limited predictive accuracy for major cardiac events, which are often precipitated by transient physiological changes that are not captured through conventional risk models or routine clinical assessment.
This prospective observational study aims to investigate whether short-term ‘physiological instability’ can be identified prior to clinical deterioration in patients with implantable cardioverter defibrillators (ICDs). Physiological instability refers to dynamic fluctuations in physiological state that may precede worsening heart failure, clinically significant arrhythmias, or other cardiovascular events. The study will examine whether short-term physiological changes and patient-reported symptoms temporally align with arrhythmic episodes and clinical events recorded by the ICD.
To capture this, participants will be provided with a commercially available wearable smartwatch capable of continuously recording physiological parameters including heart rate, heart rate variability, physical activity, and sleep patterns. Participants will also complete brief daily symptom questionnaires via a smartphone app. This wearable-derived physiological data and patient-reported outcomes (PROs) will be linked with ICD-recorded arrhythmia episodes and routine clinical outcomes collected as part of standard NHS care.
The study will recruit patients attending routine ICD follow-up at University Hospitals of North Midlands (UHNM) NHS Trust. Importantly, the study is observational only and will not alter routine clinical care or generate real-time clinical alerts.
The data generated from this project will support the development of novel risk prediction models capable of identifying clinical deterioration at an earlier stage, while also advancing the development of ‘digital endpoints’, whereby measures of ‘physiological instability’ can potentially inform clinical trial design and evaluation across broader heart failure populations.REC name
West of Scotland REC 5
REC reference
26/WS/0106
Date of REC Opinion
15 Jul 2026
REC opinion
Further Information Favourable Opinion