Detection of cardiac murmurs associated with normal and valvular heart disease in adult patients undergoing transthoracic echocardiography. Circulatory System
Conditions
Interventions
This is an observational, comparative study. Each participant will undergo a single study visit during which a clinician will perform standard auscultation using a conventional stethoscope, followed b
Sponsors
LightHearted AI Health Limited
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 years or older at the time of consent. 2. Undergoing or having undergone transthoracic echocardiography within the past 180 days, with documentation available. 3. Able and willing to provide written informed consent prior to participation. 4. Able to comply with study procedures and optional follow-up requirements, if applicable.
Exclusion criteria
Exclusion criteria: Current key exclusion criteria as of 23/01/2026: 1. Presence of an active skin infection, open wound, or dermatological condition over the neck or chest areas where the LightScope measurements would be performed. 2.Known diagnosis of congenital heart disease 3.Any cognitive, psychiatric, or physical condition that, in the opinion of the investigator, would impair the participant’s ability to comply with study procedures or provide reliable informed consent. 4. Pregnancy 5. Any previous surgical procedure or anatomical abnormality that prevents reliable recording of heart sounds from the standard measurement sites 6. Participants who are currently or have recently been involved in other research studies may be recruited, provided that their participation does not conflict with this investigation or pose any additional safety risk. As this is a non-invasive, observational study involving only contactless recording of heart sounds, clinical echocardiography and digital stethoscope auscultation, there are no overlapping safety or design considerations that would preclude co-enrolment. Each participant’s eligibility will be confirmed by the investigator prior to inclusion to ensure there are no protocol or safety conflicts with concurrent studies. _____ Previous key exclusion criteria: 1. Presence of an active skin infection, open wound, or dermatological condition over the neck or chest areas where the LightScope measurements would be performed. 2. Known diagnosis of congenital heart disease, unless a specific subgroup analysis for congenital lesions is planned. 3. Any cognitive, psychiatric, or physical condition that, in the opinion of the investigator, would impair the participant’s ability to comply with study procedures or provide reliable informed consent. 4. Any previous surgical procedure or anatomical abnormality that prevents reliable recording of heart sounds from the standard measurement sites.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Previous primary outcome(s): Murmur detection performance (sensitivity and specificity) measured using clinicians' interpretation of LightScope phonocardiograms, compared with standard auscultation, using transthoracic echocardiography (TTE) as the clinical reference at a single study visit | — |
Countries
England, United Kingdom
Contacts
Public ContactSandosh Padmanabhan
Outcome results
None listed