A Study Of Eko Digital Auscultation For Structural Heart Murmur (FLEAT STUDY)
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 26-005188
About this study
The purpose of this study is to decision-support (disease-association) performance of the FDA-cleared structural-murmur output with prespecified transthoracic echocardiography (TTE)-defined native structural heart disease composites in adults (labeling-concordant; not stand-alone diagnostic claims).
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
Exclusion Criteria:
Prior enrollment in this study.
Skin condition, wound, dressings, or isolation limitation that prevents safe or practical placement of the stethoscope.
Complex congenital heart disease
Ventricular Assist Device
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 05/11/2026. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Garvan Kane, M.D., Ph.D. |
Open for enrollment |
|
More information
Publications
Publications are currently not available