Aortic Valve StenosisALERTNCT06099665
Addressing Under-treatment and Health Equity in AS and MR Using an Integrated EHR Platform
A study testing Automated alert in people with Aortic Valve Stenosis and Mitral Regurgitation, run by Tempus AI at 6 sites in United States.
Trial summary
This multi-center, prospective, cluster-randomized controlled trial will evaluate Tempus Next automated notifications as an intervention to support identification and evaluation of patients possibly indicated for Valve Intervention (VI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis, Mitral Regurgitation
- What is being tested?
- Automated alert
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,118 participants
- Where
- 6 sitesUnited States
- Study dates
- 27 Aug 2024to 1 Dec 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
None listed.
Who cannot join
- Age < 18 years
- Patient had evidence of a prior transcatheter or surgical repair or replacement of the target valve
- The echocardiogram was ordered by a cardiologist on the MHT or a cardiac surgeon
- Patient already has a scheduled clinic visit with a member of the MHT or a recent (since the start of the study at that site ) clinic visit with the MHT, or a scheduled transcatheter or surgical VI in the future.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
OhioHealth
Columbus, Ohio, 43202
Saint Luke's Health System
Kansas City, Missouri, 64111
Bon Secours Mercy Health - Lima Market
Lima, Ohio, 45801
Vanderbilt
Nashville, Tennessee, 37235
Oregon Health and Science University
Portland, Oregon, 97239
Bon Secours Mercy Health - Richmond Market
Richmond, Virginia, 23223
About this study
Official title: Addressing Under-treatment and Health Equity in Aortic Stenosis and Mitral Regurgitation Using an Integrated EHR Platform
This multi-center, prospective, cluster-randomized controlled trial will evaluate Tempus Next automated notifications as an intervention to support identification and evaluation of patients possibly indicated for Valve Intervention (VI). This study will evaluate the impact of Tempus Next's automated notifications on: (1) Transcatheter or surgical procedure for AS or MR; and (2) Clinic visit with at least one member of the Multidisciplinary Heart Team (including time to evaluation) for patients with definitive or possible severe AS or MR on echocardiogram. These endpoints will also be examined within and between assigned groups according to race, ethnicity, sex, and geography.
The primary question that will be answered:
Read more
Do automated alerts sent to clinical providers decrease under-treatment of severe aortic stenosis and severe mitral regurgitation?
The study will compare the rate of clinical follow-up and aortic valve surgery in a control group (no alerts sent) to a treatment group (alerts sent to an appropriate care provider).
- Conditions
- Aortic Valve Stenosis, Mitral Regurgitation
- Being tested
- Automated alert
- Medical subject headings
- Aortic Valve Stenosis, Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automated alertBehavioural
Receiving an automated alert via the EHR to highlight that the patient in question presents for severe aortic stenosis or severe mitral regurgitation according to the AHA guidelines and that they are a good candidate for valve intervention. The alert will not list any specific manufacturer's device.
| Study group | Role | What they receive |
|---|---|---|
| Automated alert | Experimental | Providers that will receive an automated alert sent via the EHR. Receives: Behavioral: Automated alert |
| Control | No intervention | Care providers in the control arm will not receive an automated alert. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establish impact of automated alerts on the hierarchical composite endpoint of valve intervention (VI) or follow-up visit with a multi-disciplinary heart team (MHT).
Determining whether an automated alert improves recognition and management of severe AS and severe MR through its impact on the utilization of VI or follow-up visit with MHT, which is defined as the proportion of patients with a clinical indication for severe AS or severe MR that undergo VI or have a follow-up visit with MHT. We will utilize an automated alert to highlight TTE results that are consistent with or may be consistent with severe AS and severe MR for patients that do not have a scheduled follow-up with the MHT or an AVR procedure.
Measured: 90 days from a qualifying echocardiogram indicating severe aortic stenosis or mitral regurgitation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study start27 Aug 2024
- Primary completion1 Dec 2025
- Study completion1 Dec 2025
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 Aortic Valve StenosisStudies of the same condition, open and under way.
- More trials run by Tempus AIThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,118 participants (actual)
Sponsor and investigators
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06099665
- Sponsor's protocol ID
- TMPS-Cardio-01
- Acronym
- ALERT
- Status last verified
- Mar 2026
- First submitted
- 19 Oct 2023
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Batchelor WB, Lindman BR, Coylewright M, Keller A, Wehman B, Chhatriwalla A, Patel SM, Stiver K, Zahr F, Sotelo M, Shin D, Rogers C, Hickey GL, Williams J, Fan M, Vemulapalli S. Automated Alerts to Improve Timely Evaluation and Treatment of Valvular Heart Disease: The ALERT Trial. J Am Coll Cardiol. 2026 Jun 16;87(23):3335-3346. doi: 10.1016/j.jacc.2026.03.037. Epub 2026 Mar 29.
PubMed 42059855
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Under-treatment and Health Equity in Aortic Stenosis and Mitral Regurgitation Using an Integrated EHR Platform
- ClinicalTrials.gov ID
- NCT06099665
- Acronym / sponsor ID
- ALERT / TMPS-Cardio-01
- Conditions
- Aortic Valve Stenosis, Mitral Regurgitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,118 participants (actual)
- Lead sponsor
- Tempus AIIndustry (pharma, biotech, devices)
- Collaborators
- Medtronic
- Study start
- 27 Aug 2024 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 25 Oct 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.
This multi-center, prospective, cluster-randomized controlled trial will evaluate Tempus Next automated notifications as an intervention to support identification and evaluation of patients possibly indicated for Valve Intervention (VI). This study will evaluate the impact of Tempus Next's automated notifications on: (1) Transcatheter or surgical procedure for AS or MR; and (2) Clinic visit with at least one member of the Multidisciplinary Heart Team (including time to evaluation) for patients with definitive or possible severe AS or MR on echocardiogram. These endpoints will also be examined within and between assigned groups according to race, ethnicity, sex, and geography.
The primary question that will be answered:
Do automated alerts sent to clinical providers decrease under-treatment of severe aortic stenosis and severe mitral regurgitation?
The study will compare the rate of clinical follow-up and aortic valve surgery in a control group (no alerts sent) to a treatment group (alerts sent to an appropriate care provider).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Automated alert | Experimental | Behavioral: Automated alertProviders that will receive an automated alert sent via the EHR. |
| Control | No intervention | –Care providers in the control arm will not receive an automated alert. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- Age < 18 years
- Patient had evidence of a prior transcatheter or surgical repair or replacement of the target valve
- The echocardiogram was ordered by a cardiologist on the MHT or a cardiac surgeon
- Patient already has a scheduled clinic visit with a member of the MHT or a recent (since the start of the study at that site ) clinic visit with the MHT, or a scheduled transcatheter or surgical VI in the future.
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 |
|---|---|---|
| Automated alertReceiving an automated alert via the EHR to highlight that the patient in question presents for severe aortic stenosis or severe mitral regurgitation according to the AHA guidelines and that they are a good candidate for valve intervention. The alert will not list any specific manufacturer's device. | Behavioural | Automated alert |
Primary outcome
Establish impact of automated alerts on the hierarchical composite endpoint of valve intervention (VI) or follow-up visit with a multi-disciplinary heart team (MHT).
Time frame: 90 days from a qualifying echocardiogram indicating severe aortic stenosis or mitral regurgitation
Determining whether an automated alert improves recognition and management of severe AS and severe MR through its impact on the utilization of VI or follow-up visit with MHT, which is defined as the proportion of patients with a clinical indication for severe AS or severe MR that undergo VI or have a follow-up visit with MHT. We will utilize an automated alert to highlight TTE results that are consistent with or may be consistent with severe AS and severe MR for patients that do not have a scheduled follow-up with the MHT or an AVR procedure.
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 6 Mar 2026.
- Derived from this study: PubMed 42059855Batchelor WB, Lindman BR, Coylewright M, Keller A, Wehman B, Chhatriwalla A, Patel SM, Stiver K, Zahr F, Sotelo M, Shin D, Rogers C, Hickey GL, Williams J, Fan M, Vemulapalli S. Automated Alerts to Improve Timely Evaluation and Treatment of Valvular Heart Disease: The ALERT Trial. J Am Coll Cardiol. 2026 Jun 16;87(23):3335-3346. doi: 10.1016/j.jacc.2026.03.037. Epub 2026 Mar 29.
- 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.
Wayne Batchelor, MD principal investigator
Director of Interventional Cardiology Inova Heart and Vascular Institute
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Automated alert in people with Aortic Valve Stenosis and Mitral Regurgitation, run by Tempus AI at 6 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 0 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 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
Establish impact of automated alerts on the hierarchical composite endpoint of valve intervention (VI) or follow-up visit with a multi-disciplinary heart team (MHT). (time frame: 90 days from a qualifying echocardiogram indicating severe aortic stenosis or mitral regurgitation). 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 NCT06099665, 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 6 Mar 2026.