Murmur, HeartNCT05459545
Real-World Evaluation of Eko Algorithms in a Point of Care Setting
An observational study of Murmur, Heart and Innocent Murmurs, run by Eko Devices, Inc. at 5 sites in United States.
Trial summary
The purpose of this research is to prospectively test and validate the utility of Eko artificial intelligence (AI) plus Eko Murmur Analysis Software (EMAS) murmur characterization in algorithm in a real world, point-of-care setting. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Murmur, Heart, Innocent Murmurs, Heart Murmurs
- What is being tested?
- Use of Eko CORE and Eko CORE 500 electronic stethoscope
- Type of treatment
- Medical device
- How many people
- 371 participants
- Where
- 5 sitesUnited States
- Study dates
- 15 Apr 2022to 30 Jun 2023
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Adult primary care clinic
Who may be able to join
- Patient consents to participation
- Willing to have heart sounds recorded with an electronic stethoscope
- Willing to undergo echocardiography
- Willing to undergo a 12-lead electrocardiogram
- Adults aged 65 years and older
- History of at least one of the following: hypertension, BMI ≥ 30, diabetes mellitus, hyperlipidemia, atrial fibrillation, myocardial infarction, stroke/TIA, previous coronary surgery, or previous coronary angiography
- No prior diagnosis of valve disease or heart murmur
Who cannot join
- Patient is unwilling or unable to give written informed consent
- Patients experiencing a known or suspected acute cardiac event
- Under the age of 65 years old
- Prior diagnosis of valve disease or heart murmurs
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Maria Medical Center
Dunn, North Carolina, 27546
Pentucket Medical Associates
Haverhill, Massachusetts, 01830
Pentucket Medical Associates
Lawrence, Massachusetts, 01843
Edgewater Medical Center
Lillington, North Carolina, 27546
Hometown Medical PLLC
Lillington, North Carolina, 27546
About this study
The purpose of this research is to prospectively test and validate the utility of Eko artificial intelligence (AI) plus Eko Murmur Analysis Software (EMAS) murmur characterization in algorithm in a real world, point-of-care setting.
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 November 2019, the US Food and Drug Administration (FDA) granted Eko a 510(k) clearance for the marketing of "Eko AI", a set of machine learning algorithms that includes atrial fibrillation (AF) and heart murmur detection. The detection of heart murmurs may aid in detecting occult and dangerous valvular heart disease (VHD). Other Eko AI outputs include bradycardia, tachycardia, noisy signal, QRS duration, and unclassified data. Eko AI has accuracy comparable to physician judgment (atrial fibrillation sensitivity of 98.9% and specificity of 96.9%, murmur sensitivity of 87.6% and specificity of 87.8%). Both AF and VHD can cause significant morbidity and mortality when missed or diagnosed late.
Eko has further developed the murmur detection function of Eko AI to now not only identify whether a murmur is present, but also to inform the clinician of its timing during the cardiac cycle (systole vs diastole), and whether it is innocent or structural. We are calling this product the Eko Murmur Analysis Software (EMAS) and submitted a premarket notification to FDA in December 2021.
This study sets out to understand the utility of the Eko AI plus EMAS murmur characterization algorithm in real world use. Collecting data in a point-of-care setting will demonstrate how accurately the algorithm characterizes murmurs in comparison to an AI-unassisted clinical examination. Algorithm output and clinical determination will be confirmed by echocardiographic ground truth, with the results being blinded until the end of the patient visit.
- Being tested
- Use of Eko CORE and Eko CORE 500 electronic stethoscope
- Keywords
- artificial intelligence, machine learning
- Medical subject headings
- Heart Murmurs, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of Eko CORE and Eko CORE 500 electronic stethoscopeDevice
Auscultation of heart sounds using electronic stethoscopes
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and Specificity of Eko's AI relative to ground truth
Sensitivity and specificity of Eko's murmur detection algorithm relative to ground truth. Ground truth is defined as echocardiography-confirmed clinically-significant (graded "mild-to-moderate" or greater severity) VHD that is associated with a murmur, as confirmed by an expert panel.
Measured: 02/20/2022 - 05/20/2024
Sensitivity and Specificity of Eko's AI relative to PCP auscultation and ground truth
Sensitivity and specificity of Eko's murmur detection algorithm relative to ground truth and PCP auscultation ground truth. Ground truth is defined as echocardiography-confirmed clinically-significant (graded "mild-to-moderate" or greater severity) VHD that is associated with a murmur, as confirmed by an expert panel.
Measured: 02/20/2022 - 05/20/2024
Positive and negative predictive values for AI detecting new VHD
Positive and negative predictive values of Eko's algorithms for detecting new clinically significant valvular heart disease
Measured: 02/20/2022 - 05/20/2024
Positive and negative predictive values for PCP detecting new VHD
Positive and negative predictive values of a PCP's outpatient visit for detecting new clinically significant valvular heart disease
Measured: 02/20/2022 - 05/20/2024
Secondary outcomes (3)
Sensitivity and Specificity of Eko's AI relative to echocardiographic ground truth.
Sensitivity and specificity of Eko's murmur detection algorithm relative to echocardiographic ground truth.
Measured: 02/20/2022 - 05/20/2024
Performance of the machine algorithm vs. the physician
Performance of the machine algorithm vs. the physician
Measured: 02/20/2022 - 05/20/2024
Number of cardiac tests and consultations ordered
Number of cardiac tests and consultations ordered
Measured: 02/20/2022 - 05/20/2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2022
- Study start15 Apr 2022
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
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
- 371 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
- NCT05459545
- Sponsor's protocol ID
- 2021.11
- Status last verified
- Nov 2024
- First submitted
- 13 Jul 2022
- Last updated
- 25 Nov 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 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Evaluation of Eko Algorithms in a Point of Care Setting
- ClinicalTrials.gov ID
- NCT05459545
- Acronym / sponsor ID
- 2021.11
- Keywords
- artificial intelligence, machine learning
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 371 participants (actual)
- Lead sponsor
- Eko Devices, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Apr 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 15 Jul 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 prospectively test and validate the utility of Eko artificial intelligence (AI) plus Eko Murmur Analysis Software (EMAS) murmur characterization in algorithm in a real world, point-of-care setting.
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 November 2019, the US Food and Drug Administration (FDA) granted Eko a 510(k) clearance for the marketing of "Eko AI", a set of machine learning algorithms that includes atrial fibrillation (AF) and heart murmur detection. The detection of heart murmurs may aid in detecting occult and dangerous valvular heart disease (VHD). Other Eko AI outputs include bradycardia, tachycardia, noisy signal, QRS duration, and unclassified data. Eko AI has accuracy comparable to physician judgment (atrial fibrillation sensitivity of 98.9% and specificity of 96.9%, murmur sensitivity of 87.6% and specificity of 87.8%). Both AF and VHD can cause significant morbidity and mortality when missed or diagnosed late.
Eko has further developed the murmur detection function of Eko AI to now not only identify whether a murmur is present, but also to inform the clinician of its timing during the cardiac cycle (systole vs diastole), and whether it is innocent or structural. We are calling this product the Eko Murmur Analysis Software (EMAS) and submitted a premarket notification to FDA in December 2021.
This study sets out to understand the utility of the Eko AI plus EMAS murmur characterization algorithm in real world use. Collecting data in a point-of-care setting will demonstrate how accurately the algorithm characterizes murmurs in comparison to an AI-unassisted clinical examination. Algorithm output and clinical determination will be confirmed by echocardiographic ground truth, with the results being blinded until the end of the patient visit.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Adult primary care clinic
Key inclusion criteria (7 listed)
- Patient consents to participation
- Willing to have heart sounds recorded with an electronic stethoscope
- Willing to undergo echocardiography
- Willing to undergo a 12-lead electrocardiogram
- Adults aged 65 years and older
Key exclusion criteria (4 listed)
- Patient is unwilling or unable to give written informed consent
- Patients experiencing a known or suspected acute cardiac event
- Under the age of 65 years old
- Prior diagnosis of valve disease or heart murmurs
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 and Eko CORE 500 electronic stethoscopeAuscultation of heart sounds using electronic stethoscopes | Device | – |
Primary outcome
Sensitivity and Specificity of Eko's AI relative to ground truth
Time frame: 02/20/2022 - 05/20/2024
Sensitivity and specificity of Eko's murmur detection algorithm relative to ground truth. Ground truth is defined as echocardiography-confirmed clinically-significant (graded "mild-to-moderate" or greater severity) VHD that is associated with a murmur, as confirmed by an expert panel.
Sensitivity and Specificity of Eko's AI relative to PCP auscultation and ground truth
Time frame: 02/20/2022 - 05/20/2024
Sensitivity and specificity of Eko's murmur detection algorithm relative to ground truth and PCP auscultation ground truth. Ground truth is defined as echocardiography-confirmed clinically-significant (graded "mild-to-moderate" or greater severity) VHD that is associated with a murmur, as confirmed by an expert panel.
Positive and negative predictive values for AI detecting new VHD
Time frame: 02/20/2022 - 05/20/2024
Positive and negative predictive values of Eko's algorithms for detecting new clinically significant valvular heart disease
Positive and negative predictive values for PCP detecting new VHD
Time frame: 02/20/2022 - 05/20/2024
Positive and negative predictive values of a PCP's outpatient visit for detecting new clinically significant valvular heart disease
3 secondary outcomes
Sensitivity and Specificity of Eko's AI relative to echocardiographic ground truth.
Time frame: 02/20/2022 - 05/20/2024
Performance of the machine algorithm vs. the physician
Time frame: 02/20/2022 - 05/20/2024
Number of cardiac tests and consultations ordered
Time frame: 02/20/2022 - 05/20/2024
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 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.
5 sites 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 5 sites 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 7 inclusion and 4 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: finished, as of the sponsor's last update on 25 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Sensitivity and Specificity of Eko's AI relative to ground truth (time frame: 02/20/2022 - 05/20/2024). The study lists 4 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 25 Nov 2024.