Prospective Evaluation of AI-ECG for SHD Detection

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 to 90 years
• All sexes
• No healthy volunteers
• Adult, Older adult

Study population: This multicentre prospective observational diagnostic accuracy study will recruit 590 adult inpatients and outpatients aged 18-90 years undergoing transthoracic echocardiography (TTE) as part of routine clinical care. Participants will be recruited from Chelsea and Westminster Hospital, West Middlesex University Hospital, Hammersmith Hospital, St Mary's Hospital, Bristol Royal Infirmary, and Southmead Hospital. Patients with known severe structural heart disease are excluded. Patients with previously diagnosed structural abnormalities that do not meet the prespecified severe structural heart disease exclusion criteria may remain eligible for recruitment.

Trial locations and contacts

6 sites in 1 country. Contact the study team or a site near you to ask about taking part.

About this study

Official title: Prospective Evaluation of Artificial Intelligence-enhanced Electrocardiography for Detection of Structural Heart Disease

Conditions

Valvular Heart Disease Stenosis and Regurgitation (Diagnosis), Pulmonary Hypertension (Diagnosis), Heart Failure With Reduced Ejection Fraction (HFrEF; Diagnosis), Heart Failure With Preserved Ejection Fraction (HFpEF; Diagnosis)

Being tested

Traditional 12-lead Electrocardiogram, Apple Watch Series 4 Single-lead Electrocardiogram, Eko Core 500 Digital Stethoscope 3-lead Electrocardiogram, AliveCor KardiaMobile Single- and 6-lead Electrocardiogram, Phlebotomy for N-terminal pro-B-type natriuretic peptide

Keywords

Artificial Intelligence, Machine Learning, Wearable Devices, Portable Devices, Heart Failure, Pulmonary Hypertension, Valvular Heart Disease, Echocardiography, Electrocardiography

Medical subject headings

Gastroesophageal Reflux, Disease, Hypertension, Pulmonary, Heart Failure, Heart Valve Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Traditional 12-lead ElectrocardiogramOther

  A study-specific standard 12-lead ECG recording will be obtained with the participant in a semi-reclined position. A 10-second ECG will be acquired and pseudonymised for subsequent offline AI-ECG analysis. AI-ECG outputs will not be used to inform or alter clinical care.

• Apple Watch Series 4 Single-lead ElectrocardiogramOther

  A 30-second single-lead ECG will be recorded using an Apple Watch Series 4. The watch will be worn on the participant's left wrist and the participant will place their right index finger on the Digital Crown during recording. The ECG will be used for subsequent offline AI-ECG analysis and will not inform clinical care.

• Eko Core 500 Digital Stethoscope 3-lead ElectrocardiogramOther

  A 30-second 3-lead ECG will be recorded using the Eko CORE 500 digital stethoscope with the participant seated. The device will be positioned over the upper left parasternal region. The ECG will be used for subsequent offline AI-ECG analysis and will not inform clinical care.

• AliveCor KardiaMobile Single- and 6-lead ElectrocardiogramOther

  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. Recordings will be used for subsequent offline AI-ECG analysis and will not inform clinical care.

• Phlebotomy for N-terminal pro-B-type natriuretic peptideOther

  A single 10 mL venous blood sample will be collected from the prespecified subgroup of 203 participants for measurement of serum NT-proBNP. Samples will be analysed by the relevant hospital clinical biochemistry laboratory and disposed of after testing. Eligible same-day NT-proBNP measurements obtained as part of routine NHS care may also be included without an additional blood sample. NT-proBNP results collected for the study will not be used to alter clinical care.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. AI-ECG model classification performance for detection of structural heart disease

   Diagnostic performance of the AI-ECG models for detection of heart failure (HF), pulmonary hypertension (PH), and valvular heart disease (VHD) will be evaluated separately across conventional 12-lead, derived single-lead, and device-acquired single-, 3-, and 6-lead ECG modalities. The primary measure of model discrimination will be the area under the receiver operating characteristic curve (AUROC).

   Measured: Single study visit on the day of clinically indicated TTE (approximately 30-35 minutes); diagnostic performance calculated following completion of data collection.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted9 Jul 2025
2. Study start4 Nov 2025
3. Primary completion3 May 2027 (estimated)
4. Study completion2 Aug 2027 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Valvular Heart Disease Stenosis and Regurgitation (Diagnosis)Studies of the same condition, open and under way.
• More trials run by Imperial College LondonThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.