Heart MurmursEkoNMNCT06155643
EKO SENSORA: Detecting Clinically Significant Murmurs
A study testing Eko Sensora in people with Heart Murmurs, run by Corewell Health South at 1 site in United States.
Trial summary
The Eko Artificial Intelligence (AI) has primarily been evaluated in the primary care setting. The digital stethoscope records a phonocardiogram of heart sounds of the patient and uses machine learning artificial intelligence to identify if there are abnormalities present (Eko Health, 2023). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Murmurs
- What is being tested?
- Eko Sensora
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Oct 2023to 26 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Chief complaint of chest pain, shortness of breath, difficulty breathing, or syncope/near-syncope.
- Patients with chief complaint of Weakness would be eligible if over the age of 50 and have a history of at least two of hypertension, BMI>/= 30, diabetes, hyperlipidemia, atrial fibrillation, heart attack, stroke/Transient ischemic attack, prior cardiac surgery or angiography
Who cannot join
- Contact isolation patients
- Pediatric patients under the age of 18
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Corewell Health Lakeland
Saint Joseph, Michigan, 49085
Amanda Borchardt, PhD, 2699838679, amanda.borchardt@corewellhealth.org
Matthew Hysell, MD, matthew.hysell@corewellhealth.org
About this study
The Eko Artificial Intelligence (AI) has primarily been evaluated in the primary care setting. The digital stethoscope records a phonocardiogram of heart sounds of the patient and uses machine learning artificial intelligence to identify if there are abnormalities present (Eko Health, 2023).
The Eko SENSORA will be tested in the emergency department. Chest pain, fatigue, shortness of breath and syncope are all symptoms that could indicate a cardiac dysfunction.
The hypothesis is that this device will allow us increased ability to detect valvular heart disease that is clinically significant.
- Conditions
- Heart Murmurs
- Being tested
- Eko Sensora
- Keywords
- eko, heart murmur, ai, machine learning, heart murmur detection
- Medical subject headings
- Heart Murmurs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eko SensoraDevice
The exam involves placing the stethoscope in the aortic, pulmonic, tricuspid, and mitral areas for 15-30 seconds until a green light is displayed indicating that useful sound has been recorded. The recording is then uploaded by the device using wi-fi to the AI program for analysis. It does not carry patient identifiers. The device then indicates whether a clinically significant heart murmur was heard, and if so in which recording.
| Study group | Role | What they receive |
|---|---|---|
| Eko Device | Other | Patients with cardiac risk factors Receives: Device: Eko Sensora |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of new clinically significant heart murmurs detected
Measured: through study completion, an average of 90 days
Secondary outcomes (1)
Number of echocardiograms ordered
Measured: through study completion, an average of 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2023
- Study start26 Oct 2023
- Primary completion26 Jul 2027 (estimated)
- Study completion26 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart MurmursStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Use of the Eko device
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Corewell Health South
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06155643
- Sponsor's protocol ID
- 1635
- Acronym
- EkoNM
- Status last verified
- Jul 2026
- First submitted
- 31 Oct 2023
- Last updated
- 20 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EKO SENSORA: Detecting Clinically Significant Murmurs
- ClinicalTrials.gov ID
- NCT06155643
- Acronym / sponsor ID
- EkoNM / 1635
- Conditions
- Heart Murmurs
- Keywords
- eko, heart murmur, ai, machine learning, heart murmur detection
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Corewell Health SouthUniversity, hospital or other
- Study start
- 26 Oct 2023 (actual)
- Primary completion
- 26 Jul 2027 (estimated)
- Study completion
- 26 Jul 2027 (estimated)
- First posted
- 4 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Eko Artificial Intelligence (AI) has primarily been evaluated in the primary care setting. The digital stethoscope records a phonocardiogram of heart sounds of the patient and uses machine learning artificial intelligence to identify if there are abnormalities present (Eko Health, 2023).
The Eko SENSORA will be tested in the emergency department. Chest pain, fatigue, shortness of breath and syncope are all symptoms that could indicate a cardiac dysfunction.
The hypothesis is that this device will allow us increased ability to detect valvular heart disease that is clinically significant.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Use of the Eko device
| Arm | Type | Receives |
|---|---|---|
| Eko Device | Other | Device: Eko SensoraPatients with cardiac risk factors |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Chief complaint of chest pain, shortness of breath, difficulty breathing, or syncope/near-syncope.
- Patients with chief complaint of Weakness would be eligible if over the age of 50 and have a history of at least two of hypertension, BMI>/= 30, diabetes, hyperlipidemia, atrial fibrillation, heart attack, stroke/Transient ischemic attack, prior cardiac surgery or angiography
Key exclusion criteria (2 listed)
- Contact isolation patients
- Pediatric patients under the age of 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eko SensoraThe exam involves placing the stethoscope in the aortic, pulmonic, tricuspid, and mitral areas for 15-30 seconds until a green light is displayed indicating that useful sound has been recorded. The recording is then uploaded by the device using wi-fi to the AI program for analysis. It does not carry patient identifiers. The device then indicates whether a clinically significant heart murmur was heard, and if so in which recording. | Device | Eko Device |
Primary outcome
Number of new clinically significant heart murmurs detected
Time frame: through study completion, an average of 90 days
1 secondary outcome
Number of echocardiograms ordered
Time frame: through study completion, an average of 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eko Sensora in people with Heart Murmurs, run by Corewell Health South at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Monique Luna, MS (2699838679, monique.allen@corewellhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of new clinically significant heart murmurs detected (time frame: through study completion, an average of 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.