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Life sciences · Observational Study
ClinicalTrials.gov · October 8, 2026
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Observational Study.
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Registry record from ClinicalTrials.gov (NCT07057466). This is a study registration, not published results. Lead sponsor: Imperial College London. Recruitment status: RECRUITING. Study type: OBSERVATIONAL. Enrollment: 590 participants (ESTIMATED). 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). Interventions: OTHER: 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: Phlebotomy for N-terminal pro-B-type natriuretic peptide. Primary outcome measures: AI-ECG model classification performance for detection of structural heart disease , Single study visit on the day of clinically indicated TTE (approximately 30-35 minutes); diagnostic performance calculated following completion of data collection.. Brief summary: 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.