Low Ejection FractionNCT07270692
Detection of Reduced Left Ventricular Ejection Fraction With Three-Lead ECG Using Artificial Intelligence
An observational study of Low Ejection Fraction, run by Eko Devices, Inc. at 1 site in India.
Trial summary
The main objectives of this study are to train and evaluate an algorithm that predicts whether an individual has an ejection fraction ≤ 40%, using heart sounds and a 3-lead ECG as inputs, as well as determine the impact of gender, age, and race on algorithm performance. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Low Ejection Fraction
- What is being tested?
- Eko digital stethoscopes
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 1 siteIndia
- Study dates
- 1 Aug 2025to 1 Nov 2026
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study will employ an all-comers strategy, indicating that virtually any patient who receives a standard-of-care echocardiogram may participate. The echocardiogram must be within 7 days of the CORE 500 measurements to ensure that the measured ejection fraction is contemporaneous with the heart sounds and 3-lead ECG. This will include both healthy patients and patients with low EF.
Who may be able to join
- Adults aged 18 years and older
- Able and willing to provide informed consent
- Complete a clinical echocardiogram within 7 days before or after study procedures
Who cannot join
- Unwilling or unable to provide informed consent
- Patients who are hospitalized
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site, 1 recruiting
- Recruiting
P. D. Hinduja Hospital and Medical Research Centre
Mumbai, Maharashtra, 400016
Principal Investigator, 8443563384, udaygandhe@gmail.com
About this study
The main objectives of this study are to train and evaluate an algorithm that predicts whether an individual has an ejection fraction ≤ 40%, using heart sounds and a 3-lead ECG as inputs, as well as determine the impact of gender, age, and race on algorithm performance.
- Conditions
- Low Ejection Fraction
- Being tested
- Eko digital stethoscopes
- Keywords
- low ejection fraction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eko digital stethoscopesDevice
Use of the Eko CORE 500 digital stethoscope and 3M Littmann CORE Digital Stethoscope to auscultate and record cardiac phonocardiogram and (when available) electrocardiogram waveforms, as well as heart sounds.
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Objective: Collection of Heart Sounds and 3-lead ECG Recordings to Train Algorithm
The primary objective of this study is to train and evaluate an algorithm that predicts whether an individual has an ejection fraction ≤ 40%, by using Eko CORE 500 digital stethoscopes to collect the heart sounds and 3-lead ECG recordings of 500 patients who are 18 years or older and have completed an echocardiogram within 7 days of the study procedures.
Measured: 15-16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study start1 Aug 2025
- Primary completionOct 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Ejection FractionStudies 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eko Devices, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07270692
- Sponsor's protocol ID
- 2025.5
- Status last verified
- Aug 2026
- First submitted
- 17 Nov 2025
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Reduced Left Ventricular Ejection Fraction With Three-Lead ECG Using Artificial Intelligence
- ClinicalTrials.gov ID
- NCT07270692
- Acronym / sponsor ID
- 2025.5
- Conditions
- Low Ejection Fraction
- Keywords
- low ejection fraction
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Eko Devices, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 8 Dec 2025 (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 main objectives of this study are to train and evaluate an algorithm that predicts whether an individual has an ejection fraction ≤ 40%, using heart sounds and a 3-lead ECG as inputs, as well as determine the impact of gender, age, and race on algorithm performance.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study will employ an all-comers strategy, indicating that virtually any patient who receives a standard-of-care echocardiogram may participate. The echocardiogram must be within 7 days of the CORE 500 measurements to ensure that the measured ejection fraction is contemporaneous with the heart sounds and 3-lead ECG. This will include both healthy patients and patients with low EF.
Key inclusion criteria (3 listed)
- Adults aged 18 years and older
- Able and willing to provide informed consent
- Complete a clinical echocardiogram within 7 days before or after study procedures
Key exclusion criteria (2 listed)
- Unwilling or unable to provide informed consent
- Patients who are hospitalized
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 digital stethoscopesUse of the Eko CORE 500 digital stethoscope and 3M Littmann CORE Digital Stethoscope to auscultate and record cardiac phonocardiogram and (when available) electrocardiogram waveforms, as well as heart sounds. | Device | – |
Primary outcome
Primary Objective: Collection of Heart Sounds and 3-lead ECG Recordings to Train Algorithm
Time frame: 15-16 months
The primary objective of this study is to train and evaluate an algorithm that predicts whether an individual has an ejection fraction ≤ 40%, by using Eko CORE 500 digital stethoscopes to collect the heart sounds and 3-lead ECG recordings of 500 patients who are 18 years or older and have completed an echocardiogram within 7 days of the study procedures.
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 3 Sep 2026.
- Individual participant dataSharing planned: No
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Mechanistic Clinical Trial Comparing the Pharmacokinetics/Pharmacodynamics of Metoprolol in Heart Failure With Reduced Ejection Fraction Patients With Low vs. High Polygenic Score
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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?
An observational study of Low Ejection Fraction, run by Eko Devices, Inc. at 1 site in India.
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 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 3 Sep 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 India. 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 Clinical Research Associate (8443563384, jackrin.walsh@ekohealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Objective: Collection of Heart Sounds and 3-lead ECG Recordings to Train Algorithm (time frame: 15-16 months). 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 3 Sep 2026.