Ventricular Ejection FractionAIM ECG-AINCT05867407
A Multicenter Pragmatic Implementation Study of ECG-AI-Based Clinical Decision Support Software to Identify Low LVEF
A study testing Anumana Low EF AI-ECG Algorithm and Care-as-Usual in people with Ventricular Ejection Fraction, run by Anumana, Inc. at 5 sites in United States.
Trial summary
A prospective, cluster-randomized, care-as-usual controlled trial to evaluate the impact of an ECG-based artificial intelligence (ECG-AI) algorithm to detect low left ventricular ejection fraction (LVEF) on diagnosis rates of LVEF ≤ 40% in the outpatient setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Ejection Fraction
- What is being tested?
- Anumana Low EF AI-ECG Algorithm and Care-as-Usual
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11,610 participants
- Where
- 5 sitesUnited States
- Study dates
- 13 Jun 2024to 30 May 2025
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females 18 years or older (including females who are pregnant, breastfeeding and/or lactating)
- Digital ECG captured or available within site for ECG-AI analysis at point-of-care
Who cannot join
- Known history of LVEF ≤ 40%
- Known history of systolic heart failure
- Known history of heart failure with reduced ejection fraction
- Opted out of electronic health record-based research
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Texas Southwestern
Dallas, Texas, 75390
Duke Health
Durham, North Carolina, 27710
Mayo Clinic Florida
Jacksonville, Florida, 32224
Mayo Clinic Arizona
Phoenix, Arizona, 85054
Mayo Clinic Rochester
Rochester, Minnesota, 55905
About this study
Official title: A Prospective Pragmatic Cluster-Randomized Care-as-Usual Controlled Study to Evaluate the Impact of an ECG-Based AI Algorithm to Detect Low Left Ventricular Ejection Fraction on Diagnosis Rates of LVEF ≤40% in the Outpatient Setting
A prospective, cluster-randomized, care-as-usual controlled trial to evaluate the impact of an ECG-based artificial intelligence (ECG-AI) algorithm to detect low left ventricular ejection fraction (LVEF) on diagnosis rates of LVEF ≤ 40% in the outpatient setting.
The objective of this study is to evaluate the impacts of an ECG-AI algorithm to detect low LVEF and an associated Medical Device Data System when used during routine outpatient care. The study will be conducted in 2 phases: feasibility assessment phase and clinical impact phase.
Read the detailed description
The study is a prospective, cluster randomized, care-as-usual controlled trial that will be conducted at 6 sites in the USA.
Primary care clinicians and general cardiologists will be invited and consented to participate in the study. For clinicians that accept, practice groups will be randomized to receive access to and education about the Low EF AI-ECG software and encompassing software or to provide care-as-usual in the control group. The study will be conducted in two phases: a feasibility pilot to evaluate integration and usability followed by observational period(s) to evaluate clinical outcomes.
Analyses of the primary and secondary endpoints will be conducted on data from patients that meet the inclusion and exclusion criteria. The expected duration of the study is 12 months, including a feasibility phase (estimated 6 weeks) followed by a 3-month initial observation period with rolling observation count monitoring until the target number of patient encounters is reached, followed by a 90-day follow up period.
At the completion of the feasibility period, we will evaluate quantitative and qualitative outcomes to inform the following observational period(s).
Primary endpoints and exploratory endpoints will be assessed the end of the study.
- Conditions
- Ventricular Ejection Fraction
- Being tested
- Anumana Low EF AI-ECG Algorithm, Care-as-Usual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anumana Low EF AI-ECG AlgorithmDevice
Clinician will have access to the Anumana Low EF AI-ECG algorithm via a link in the patient's electronic health record which will display results applied to patients' ECGs, as well as supporting information. Using the results of the algorithm, combined with the clinician's knowledge of patient-specific risk factors, the clinician will determine whether further evaluation is warranted.
Care-as-UsualOther
Clinicians will not have access to the Anumana Low EF AI-ECG algorithm and will provide care-as-usual.
| Study group | Role | What they receive |
|---|---|---|
| Anumana Low EF AI-ECG Algorithm | Experimental | Anumana Low EF AI-ECG Algorithm Receives: Device: Anumana Low EF AI-ECG Algorithm |
| Care-as-Usual | Other | Care-as-Usual Receives: Other: Care-as-Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis rates of low ejection fraction of less than or equal to 40 percent by echocardiography compared to care-as-usual
Diagnosis rates of low ejection fraction of less than or equal to 40 percent by echocardiography compared to care-as-usual
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start13 Jun 2024
- Primary completion30 May 2025
- Study completion30 May 2025
Why it stopped: Administrative decision following adoption of a new ECG-AI implementation workflow and slower-than-anticipated enrollment. No safety concerns; no outcome analyses were performed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ventricular 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Clinicians in primary care practice groups will be consented for enrollment into the study. Practice groups that decide to participate in the study will be randomized to have the software available or to provide care as usual without the software.
- Masking
- None (open label)
- Enrolment
- 11,610 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anumana, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Mayo Clinic
- Responsible party
- Sponsor
- Investigators
- Francisco Lopez-Jimenez, MD, MSc, MBA, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05867407
- Sponsor's protocol ID
- DOC-244
- Acronym
- AIM ECG-AI
- Status last verified
- Aug 2025
- First submitted
- 1 May 2023
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Lopez-Jimenez F, Alger HM, Attia ZI, Barry B, Chatterjee R, Dolor R, Friedman PA, Greene SJ, Greenwood J, Gundurao V, Hackett S, Jain P, Kinaszczuk A, Mehta K, O'Grady J, Pandey A, Pullins C, Puranik AR, Ranganathan MK, Rushlow D, Stampehl M, Subramanian V, Vassor K, Zhu X, Awasthi S. A multicenter pragmatic implementation study of AI-ECG-based clinical decision support software to identify low LVEF: Clinical trial design and methods. Am Heart J Plus. 2025 Mar 21;54:100528. doi: 10.1016/j.ahjo.2025.100528. eCollection 2025 Jun.
PubMed 40276542
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Pragmatic Cluster-Randomized Care-as-Usual Controlled Study to Evaluate the Impact of an ECG-Based AI Algorithm to Detect Low Left Ventricular Ejection Fraction on Diagnosis Rates of LVEF ≤40% in the Outpatient Setting
- ClinicalTrials.gov ID
- NCT05867407
- Acronym / sponsor ID
- AIM ECG-AI / DOC-244
- Conditions
- Ventricular Ejection Fraction
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Administrative decision following adoption of a new ECG-AI implementation workflow and slower-than-anticipated enrollment. No safety concerns; no outcome analyses were performed.
- Enrolment
- 11,610 participants (actual)
- Lead sponsor
- Anumana, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Mayo Clinic
- Study start
- 13 Jun 2024 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 22 May 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.
A prospective, cluster-randomized, care-as-usual controlled trial to evaluate the impact of an ECG-based artificial intelligence (ECG-AI) algorithm to detect low left ventricular ejection fraction (LVEF) on diagnosis rates of LVEF ≤ 40% in the outpatient setting.
The objective of this study is to evaluate the impacts of an ECG-AI algorithm to detect low LVEF and an associated Medical Device Data System when used during routine outpatient care. The study will be conducted in 2 phases: feasibility assessment phase and clinical impact phase.
Detailed description
The study is a prospective, cluster randomized, care-as-usual controlled trial that will be conducted at 6 sites in the USA.
Primary care clinicians and general cardiologists will be invited and consented to participate in the study. For clinicians that accept, practice groups will be randomized to receive access to and education about the Low EF AI-ECG software and encompassing software or to provide care-as-usual in the control group. The study will be conducted in two phases: a feasibility pilot to evaluate integration and usability followed by observational period(s) to evaluate clinical outcomes.
Analyses of the primary and secondary endpoints will be conducted on data from patients that meet the inclusion and exclusion criteria. The expected duration of the study is 12 months, including a feasibility phase (estimated 6 weeks) followed by a 3-month initial observation period with rolling observation count monitoring until the target number of patient encounters is reached, followed by a 90-day follow up period.
At the completion of the feasibility period, we will evaluate quantitative and qualitative outcomes to inform the following observational period(s).
Primary endpoints and exploratory endpoints will be assessed the end of the study.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Clinicians in primary care practice groups will be consented for enrollment into the study. Practice groups that decide to participate in the study will be randomized to have the software available or to provide care as usual without the software.
| Arm | Type | Receives |
|---|---|---|
| Anumana Low EF AI-ECG Algorithm | Experimental | Device: Anumana Low EF AI-ECG AlgorithmAnumana Low EF AI-ECG Algorithm |
| Care-as-Usual | Other | Other: Care-as-UsualCare-as-Usual |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Males and females 18 years or older (including females who are pregnant, breastfeeding and/or lactating)
- Digital ECG captured or available within site for ECG-AI analysis at point-of-care
Key exclusion criteria (4 listed)
- Known history of LVEF ≤ 40%
- Known history of systolic heart failure
- Known history of heart failure with reduced ejection fraction
- Opted out of electronic health record-based research
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 |
|---|---|---|
| Anumana Low EF AI-ECG AlgorithmClinician will have access to the Anumana Low EF AI-ECG algorithm via a link in the patient's electronic health record which will display results applied to patients' ECGs, as well as supporting information. Using the results of the algorithm, combined with the clinician's knowledge of patient-specific risk factors, the clinician will determine whether further evaluation is warranted. | Device | Anumana Low EF AI-ECG Algorithm |
| Care-as-UsualClinicians will not have access to the Anumana Low EF AI-ECG algorithm and will provide care-as-usual. | Other | Care-as-Usual |
Primary outcome
Diagnosis rates of low ejection fraction of less than or equal to 40 percent by echocardiography compared to care-as-usual
Time frame: 90 days
Diagnosis rates of low ejection fraction of less than or equal to 40 percent by echocardiography compared to care-as-usual
Results and safety
The study was stopped early (reason given: Administrative decision following adoption of a new ECG-AI implementation workflow and slower-than-anticipated enrollment. No safety concerns; no outcome analyses were performed.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Derived from this study: PubMed 40276542Lopez-Jimenez F, Alger HM, Attia ZI, Barry B, Chatterjee R, Dolor R, Friedman PA, Greene SJ, Greenwood J, Gundurao V, Hackett S, Jain P, Kinaszczuk A, Mehta K, O'Grady J, Pandey A, Pullins C, Puranik AR, Ranganathan MK, Rushlow D, Stampehl M, Subramanian V, Vassor K, Zhu X, Awasthi S. A multicenter pragmatic implementation study of AI-ECG-based clinical decision support software to identify low LVEF: Clinical trial design and methods. Am Heart J Plus. 2025 Mar 21;54:100528. doi: 10.1016/j.ahjo.2025.100528. eCollection 2025 Jun.
- Individual participant dataSharing planned: No
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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.
Francisco Lopez-Jimenez, MD, MSc, MBA principal investigator
Mayo Clinic
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anumana Low EF AI-ECG Algorithm and Care-as-Usual in people with Ventricular Ejection Fraction, run by Anumana, 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 2 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: stopped early, as of the sponsor's last update on 4 Sep 2025. 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 was stopped early (reason given: Administrative decision following adoption of a new ECG-AI implementation workflow and slower-than-anticipated enrollment. No safety concerns; no outcome analyses were performed.). 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?
Diagnosis rates of low ejection fraction of less than or equal to 40 percent by echocardiography compared to care-as-usual (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05867407, which also lists 1 linked publication.
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 4 Sep 2025.