At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Traditional 12-lead Electrocardiogram (other), Apple Watch Series 4 Single-lead Electrocardiogram (other), Eko Core 500 Digital Stethoscope 3-lead Electrocardiogram (other), AliveCor KardiaMobile Single- and 6-lead Electrocardiogram (other)
- How long the study runs
- Study runs about 21 months (dates as stated)
- About the drug or intervention
- Traditional 12-lead Electrocardiogram — other: A study-specific standard 12-lead ECG recording will be obtained with the participant in a semi-reclined position. · Apple Watch Series 4 Single-lead Electrocardiogram — other: A 30-second single-lead ECG will be recorded using an Apple Watch Series 4. · Eko Core 500 Digital Stethoscope 3-lead Electrocardiogram — other: A 30-second 3-lead ECG will be recorded using the Eko CORE 500 digital stethoscope with the participant seated. · AliveCor KardiaMobile Single- and 6-lead Electrocardiogram — other: Two 30-second ECG recordings will be obtained using the AliveCor KardiaMobile 6L device: a single-lead recording with the participant's thumbs placed on the upper electrodes, followed by a 6-lead recording with the thumbs on the upper electrodes and the lower electrode in contact with the left knee or ankle. · Phlebotomy for N-terminal pro-B-type natriuretic peptide — other: A single 10 mL venous blood sample will be collected from the prespecified subgroup of 203 participants for measurement of serum NT-proBNP.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Observing health over time
- Ages
- 18 Years to 90 Years
- Who
- All
- Number of participants
- 590
- Started
- 2025-11-04
- Last checked
- 2026-10
Plain English Summary
What is this study?
- • Testing a new treatment for valvular heart disease stenosis and regurgitation (diagnosis)
- • Clinical study - 590 participants
- • AI-ECG-SHD is a multicentre prospective observational diagnostic accuracy study evaluating artificial intelligence-enhanced electrocardiography (AI-ECG) for the detection of structural heart disease in adults undergoing clinically indicated transthoracic echocardiography (TTE)
Who can take part?
- • Ages 18 Years to 90 Years
- • Diagnosed with valvular heart disease stenosis and regurgitation (diagnosis)
Where?
- • Bristol - Bristol Royal Infirmary
- • Bristol - Southmead Hospital
- • London - Chelsea and Westminster Hospital
- • London - Hammersmith Hospital
- • +2 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
AI-ECG-SHD is a multicentre prospective observational diagnostic accuracy study evaluating artificial intelligence-enhanced electrocardiography (AI-ECG) for the detection of structural heart disease in adults undergoing clinically indicated transthoracic echocardiography (TTE). Participants undergo standard 12-lead ECG acquisition together with ECG recordings obtained using portable or wearable single-, 3-, and 6-lead devices. Established AI-ECG models will be evaluated for the detection of heart failure, pulmonary hypertension and valvular heart disease using TTE as the clinical reference standard, with performance compared across ECG acquisition modalities within the same prospective cohort. AI-ECG predictions are generated offline and are not provided to treating clinicians or used to alter clinical care. The study will also compare AI-ECG performance with N-terminal pro-B-type natriuretic peptide (NT-proBNP) and evaluate the diagnostic performance of a combined AI-ECG and NT-proBNP approach. The study aims to recruit 590 participants across six NHS hospital sites. A prespecified subgroup of 203 participants will undergo dedicated venous blood sampling for NT-proBNP; eligible same-day NT-proBNP measurements obtained as part of routine clinical care will also be included where available.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 90 Years
- Who can join: All genders
What the study is looking for
- ✓Inclusion Criteria
- ✓Patients awaiting a transthoracic echocardiogram (TTE) based on clinical grounds as part of their standard care
- ✓Age 18-90 years
- ✓Able to provide agreement to take part
- ✓Exclusion Criteria
See the full criteria
Where Is This Study? (6 UK sites)
Bristol Royal Infirmary
Bristol, United Kingdom
Southmead Hospital
Bristol, United Kingdom
Chelsea and Westminster Hospital
London, United Kingdom
Hammersmith Hospital
London, United Kingdom
St Mary's Hospital
London, United Kingdom
West Middlesex University Hospital
London, United Kingdom
How to Get in Touch
Ahmed YM El-Medany, MBChB, MRCP, MSc, FHEA
Sponsor contactCONTACT