NCT07202104 Improvement of an Algorithm to Detect Structural Heart Murmurs in Adult Patients Using Electronic Stethoscopes
| NCT ID | NCT07202104 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Eko Devices, Inc. |
| Condition | Structural Heart Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 125 participants |
| Start Date | 2025-09 |
| Primary Completion | 2026-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 125 participants in total. It began in 2025-09 with a primary completion date of 2026-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. Diagnosis of structural murmur will be confirmed by gold-standard echocardiography and reviewed by an expert panel of cardiologists.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07202104 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Structural Heart Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07202104 currently recruiting?
Yes, NCT07202104 is actively recruiting participants. Contact the research team at jackrin.walsh@ekohealth.com for enrollment information.
Where is the NCT07202104 trial being conducted?
This trial is being conducted at Springfield, United States.
Who is sponsoring the NCT07202104 clinical trial?
NCT07202104 is sponsored by Eko Devices, Inc.. The trial plans to enroll 125 participants.