Murmur, HeartNCT05176899
Real-World Evaluation of Eko Murmur Analysis Software in a Point of Care Setting
An observational study of Murmur, Heart and Innocent Murmurs, run by Eko Devices, Inc. at 1 site in United States.
Trial summary
The purpose of this research is to evaluate the impact of Eko AI plus EMAS (Eko Murmur Analysis Software) on a clinician's referral decision in a real-world primary care setting. There is an additional objective of understanding patient outcomes when patients are referred for cardiology follow-up and/or echocardiogram. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Murmur, Heart, Innocent Murmurs, Heart Murmurs
- What is being tested?
- Use of Eko CORE electronic stethoscope
- Type of treatment
- Medical device
- How many people
- 103 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Mar 2022to 18 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Potential research subjects will be screened by MedStar study personnel for eligibility from the onsite primary, internal medicine, and geriatric clinics at MedStar. If a patient meets all of the inclusion criteria, and none of the exclusion criteria, they will be approached for participation.
Who may be able to join
- Patient verbally consents to participation
- Patient is willing to have heart sounds recorded with an electronic stethoscope
- Patient is age 50 years or older
Who cannot join
- Patient is unwilling or unable to give verbal informed consent
- Patients experiencing a known or suspected acute cardiac event
- Patient is under the age of 50 years old
Trial locations and contacts
1 site in 1 country.
United States1 site
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
The purpose of this research is to evaluate the impact of Eko AI plus EMAS (Eko Murmur Analysis Software) on a clinician's referral decision in a real-world primary care setting. There is an additional objective of understanding patient outcomes when patients are referred for cardiology follow-up and/or echocardiogram.
Read the detailed description
Eko has developed a platform to aid in screening for cardiac conditions using a digital stethoscope and machine-learning algorithms to detect the presence or absence of heart conditions such as heart murmurs and atrial fibrillation. In June 2022, the US Food and Drug Administration (FDA) granted Eko a 510(k) clearance for the marketing of "Eko Murmur Analysis Software" (EMAS), a set of machine learning algorithms that are able to screen signal quality and identify fundamental heart sounds, distinguish structural murmurs from absent or innocent murmurs, and provide a structural murmur's timing in the cardiac cycle.
This study sets out to evaluate the impact of EMAS on a clinician's referral decision in a real-world primary care setting, with the additional objective of understanding patient outcomes when patients are referred for cardiology follow-up and/or echocardiogram. Providers will receive access to the EMAS screening tool, called the SENSORA™ Disease Detection Platform, which features the FDA cleared 3M™ Littmann® CORE stethoscope paired with the FDA cleared SENSORA™ enterprise application and EMAS AI running on an iPad, which is mounted on a Tryten stand. SENSORA™ will be used by medical assistants or equivalent as part of the initial patient intake process (e.g., during vitals acquisition).
EMAS influence on individual providers will be assessed by reviewing each provider's number of referrals to cardiology and number of echocardiogram orders for the 6 months preceding study start. These values will be compared to cardiac referral and order rates at the end of the study. Patient outcomes data (e.g., cardiology appointment notes, echocardiogram findings, follow up visits scheduled) will be pulled 6 months after the patient is seen by their primary care provider. Secondary objectives include the continued assessment of algorithm performance on a point-of-care population.
- Conditions
- Murmur, Heart, Innocent Murmurs, Heart Murmurs, Pathologic Murmur
- Being tested
- Use of Eko CORE electronic stethoscope
- Keywords
- artificial intelligence, machine learning
- Medical subject headings
- Heart Murmurs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of Eko CORE electronic stethoscopeDevice
Recording of heart sounds using electronic stethoscope
| Study group | Role | What they receive |
|---|---|---|
| Prospective cohort | Patients who are at least 50 years of age during their primary care exam will undergo SENSORA™ screening if they provide consent. Receives: Device: Use of Eko CORE electronic stethoscope | |
| Retrospective cohort | Patients who saw participating providers in the 6 months prior to study start date, and who were referred to echocardiogram and/or cardiology, will be included as provider self-control for patient outcomes and referral rates. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of EMAS on echocardiogram order rates
Echocardiogram order rates before and after SENSORA implementation, for individual providers and aggregated for the site as a whole
Measured: 01/17/2022 - 11/30/2023
Impact of EMAS on cardiologist consult order rates
Cardiology consultation referral rates before and after SENSORA implementation, for individual providers and aggregated for the site as a whole
Measured: 01/17/2022 - 11/30/2023
Impact of EMAS on provider decision-making
Impact of EMAS on provider decision to refer to echocardiogram, cardiologist, or other workup related to cardiac murmur. Measured via a survey administered to each provider after each patient is screened, which asks if SENSORA AI influenced their decision to refer or not to refer. Measured for individual providers and aggregated for the site as a whole.
Measured: 01/17/2022 - 11/30/2023
Secondary outcomes (2)
Impact of EMAS on patient outcomes
VHD discovery rates before and after SENSORA platform implementation, for individual providers and aggregated for the site as a whole
Measured: 01/17/2022 - 11/30/2023
Sensitivity and specificity
EMAS' accuracy (sensitivity and specificity) in detecting structural murmur, compared to an annotator panel
Measured: 01/17/2022 - 11/30/2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2022
- Study start11 Mar 2022
- Primary completion3 Aug 2023
- Study completion18 Jan 2024
Why it stopped: Data collection complete
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Murmur, HeartStudies 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
- 103 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
- NCT05176899
- Sponsor's protocol ID
- 2021.12
- Status last verified
- Sep 2024
- First submitted
- 15 Dec 2021
- Last updated
- 19 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All participant data will be de-identified. Data will only be shared with Eko Devices, and not shared with any other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Evaluation of Eko Murmur Analysis Software in a Point of Care Setting
- ClinicalTrials.gov ID
- NCT05176899
- Acronym / sponsor ID
- 2021.12
- Conditions
- Murmur, Heart, Innocent Murmurs, Heart Murmurs, Pathologic Murmur
- Keywords
- artificial intelligence, machine learning
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Data collection complete
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Eko Devices, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Mar 2022 (actual)
- Primary completion
- 3 Aug 2023 (actual)
- Study completion
- 18 Jan 2024 (actual)
- First posted
- 4 Jan 2022 (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 purpose of this research is to evaluate the impact of Eko AI plus EMAS (Eko Murmur Analysis Software) on a clinician's referral decision in a real-world primary care setting. There is an additional objective of understanding patient outcomes when patients are referred for cardiology follow-up and/or echocardiogram.
Detailed description
Eko has developed a platform to aid in screening for cardiac conditions using a digital stethoscope and machine-learning algorithms to detect the presence or absence of heart conditions such as heart murmurs and atrial fibrillation. In June 2022, the US Food and Drug Administration (FDA) granted Eko a 510(k) clearance for the marketing of "Eko Murmur Analysis Software" (EMAS), a set of machine learning algorithms that are able to screen signal quality and identify fundamental heart sounds, distinguish structural murmurs from absent or innocent murmurs, and provide a structural murmur's timing in the cardiac cycle.
This study sets out to evaluate the impact of EMAS on a clinician's referral decision in a real-world primary care setting, with the additional objective of understanding patient outcomes when patients are referred for cardiology follow-up and/or echocardiogram. Providers will receive access to the EMAS screening tool, called the SENSORA™ Disease Detection Platform, which features the FDA cleared 3M™ Littmann® CORE stethoscope paired with the FDA cleared SENSORA™ enterprise application and EMAS AI running on an iPad, which is mounted on a Tryten stand. SENSORA™ will be used by medical assistants or equivalent as part of the initial patient intake process (e.g., during vitals acquisition).
EMAS influence on individual providers will be assessed by reviewing each provider's number of referrals to cardiology and number of echocardiogram orders for the 6 months preceding study start. These values will be compared to cardiac referral and order rates at the end of the study. Patient outcomes data (e.g., cardiology appointment notes, echocardiogram findings, follow up visits scheduled) will be pulled 6 months after the patient is seen by their primary care provider. Secondary objectives include the continued assessment of algorithm performance on a point-of-care population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prospective cohort | – | Device: Use of Eko CORE electronic stethoscopePatients who are at least 50 years of age during their primary care exam will undergo SENSORA™ screening if they provide consent. |
| Retrospective cohort | – | –Patients who saw participating providers in the 6 months prior to study start date, and who were referred to echocardiogram and/or cardiology, will be included as provider self-control for patient outcomes and referral rates. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Potential research subjects will be screened by MedStar study personnel for eligibility from the onsite primary, internal medicine, and geriatric clinics at MedStar. If a patient meets all of the inclusion criteria, and none of the exclusion criteria, they will be approached for participation.
Key inclusion criteria (3 listed)
- Patient verbally consents to participation
- Patient is willing to have heart sounds recorded with an electronic stethoscope
- Patient is age 50 years or older
Key exclusion criteria (3 listed)
- Patient is unwilling or unable to give verbal informed consent
- Patients experiencing a known or suspected acute cardiac event
- Patient is under the age of 50 years old
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 |
|---|---|---|
| Use of Eko CORE electronic stethoscopeRecording of heart sounds using electronic stethoscope | Device | Prospective cohort |
Primary outcome
Impact of EMAS on echocardiogram order rates
Time frame: 01/17/2022 - 11/30/2023
Echocardiogram order rates before and after SENSORA implementation, for individual providers and aggregated for the site as a whole
Impact of EMAS on cardiologist consult order rates
Time frame: 01/17/2022 - 11/30/2023
Cardiology consultation referral rates before and after SENSORA implementation, for individual providers and aggregated for the site as a whole
Impact of EMAS on provider decision-making
Time frame: 01/17/2022 - 11/30/2023
Impact of EMAS on provider decision to refer to echocardiogram, cardiologist, or other workup related to cardiac murmur. Measured via a survey administered to each provider after each patient is screened, which asks if SENSORA AI influenced their decision to refer or not to refer. Measured for individual providers and aggregated for the site as a whole.
2 secondary outcomes
Impact of EMAS on patient outcomes
Time frame: 01/17/2022 - 11/30/2023
Sensitivity and specificity
Time frame: 01/17/2022 - 11/30/2023
Results and safety
The study was stopped early (reason given: Data collection complete). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No. All participant data will be de-identified. Data will only be shared with Eko Devices, and not shared with any other researchers.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Murmur, Heart and Innocent Murmurs, run by Eko Devices, Inc. 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 3 inclusion and 3 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: stopped early, as of the sponsor's last update on 19 Sep 2024. 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?
The study was stopped early (reason given: Data collection complete). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of EMAS on echocardiogram order rates (time frame: 01/17/2022 - 11/30/2023). The study lists 3 primary outcomes in all. 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 19 Sep 2024.