Structural Heart DiseaseNCT07202104
Improvement of an Algorithm to Detect Structural Heart Murmurs in Adult Patients Using Electronic Stethoscopes
An observational study of Structural Heart Disease, run by Eko Devices, Inc. at 1 site in United States.
Trial summary
The main objective of this study is to evaluate a machine learning model's ability to detect murmurs indicative of structural heart disease ("structural murmur") by analyzing phonocardiogram waveforms-and simultaneous electrocardiogram waveforms when available-in multiple auscultatory positions per subject. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Structural Heart Disease
- What is being tested?
- Eko digital stethoscopes
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jun 2026to 29 Jun 2026
- Phase
- Observational
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Potential research subjects will be screened for eligibility from cardiology clinics, echocardiogram clinics, and inpatient areas. In order to be eligible, a patient must be 18+ years of age, have a documented history of structural heart disease, and has undergone an echocardiogram within the last 30 days. If a patient meets all of the specified inclusion criteria, and none of the specified exclusion criteria, the patient or their proxy will be approached to discuss participation in the study.
Who may be able to join
- 18+ years old
- Patient or patient's legal healthcare proxy consents to participation
- Documented history of SHD
- Undergoing (or has undergone, within 30 days) a complete echocardiogram
- Willing to have heart recordings done with two different electronic stethoscopes
Who cannot join
- Patient or proxy is unwilling/unable to give written informed consent
- Unable to complete a complete echocardiogram, or none recent completed within the last 30 days
- No documented history of SHD
- Experiencing a known or suspected acute cardiac event
- Mechanical ventricular support (such as ECMO, LVAD, RVAD, BiVAD, Impella, intra-aortic balloon pumps, TAH, VentrAssist, DuraHeart, HVAD, EVAHEART LVAS, HeartMate, Jarvik 2000)
- Unwilling or unable to follow or complete study procedures
Trial locations and contacts
1 site in 1 country.
About this study
The main objective of this study is to evaluate a machine learning model's ability to detect murmurs indicative of structural heart disease ("structural murmur") by analyzing phonocardiogram waveforms-and simultaneous electrocardiogram waveforms when available-in multiple auscultatory positions per subject. Diagnosis of structural murmur will be confirmed by gold-standard echocardiography and reviewed by an expert panel of cardiologists.
- Conditions
- Structural Heart Disease
- Being tested
- Eko digital stethoscopes
- Keywords
- structural heart disease, structural murmur
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eko digital stethoscopesDevice
Use of the Eko CORE 500 digital stethoscope and 3M Littmann CORE Digital Stethoscope to auscultate and record cardiac phonocardiogram and (when available) electrocardiogram waveforms, as well as heart sounds.
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome
Evaluate a machine learning model's ability to detect murmurs indicative of structural heart disease ("structural murmur") by analyzing phonocardiogram waveforms-and simultaneous electrocardiogram waveforms when available-in multiple auscultatory positions per subject. Diagnosis of structural murmur will be confirmed by gold-standard echocardiography and review by an expert panel of cardiologists.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start29 Jun 2026
- Primary completion29 Jun 2026
- Study completion29 Jun 2026
Why it stopped: The original PI of the study announced his resignation from the organization. The organization has not hired a replacement interventional/structural heart cardiologist. Organization decided to terminate the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Structural Heart DiseaseStudies of the same condition, open and under way.
- 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.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eko Devices, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07202104
- Sponsor's protocol ID
- 2025.1
- Status last verified
- Sep 2025
- First submitted
- 23 Sep 2025
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No