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EHR alerts aim to close gap in heart valve care

NCT ID NCT06099665

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether automated alerts in electronic health records help doctors identify and treat patients with severe aortic stenosis or mitral regurgitation. Over 2,100 patients were included, and some doctors received alerts while others did not. The goal was to see if alerts increase the number of patients who get a heart valve procedure or see a heart specialist, and whether this reduces racial, ethnic, and geographic gaps in care.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Automated alert via electronic health record (EHR)
What this could lead to
If successful, this could show that simple computer alerts help doctors catch and treat severe heart valve problems earlier, especially in groups that often miss out on care.
What could go wrong
This is a completed study, so results are known but not yet widely applied. Alerts may not change doctor behavior enough, or benefits may not hold across all hospitals or patient groups.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

2,118 people

The number who actually took part.

Started

Aug 2024

Finished

Dec 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

At least one of the following three options for aortic stenosis and/or the single option for mitral regurgitation are determined from echocardiogram findings: 1. AVA or DI (Patients with either Aortic valve area (AVA) or Dimensionless Index (DI) measured in their echo as well as at least one hemodynamic measure above the minimum threshold) a. Either: i. Aortic Valve Area ≤ 1.0 cm2 ii. Dimensionless Index ≤ 0.25 b. AND ANY of i. Aortic Mean Gradient ≥ 15 mmHg ii. Aortic Peak Gradient ≥ 30 mmHg iii. Aortic Jet Velocity ≥ 2.75 m/s 2. AVA + OTHER (Patients with AVA and at least 1 other echo measurement in their echo above the threshold) 1. 1.0 cm2 \< Aortic Valve Area ≤ 1.2 cm2 2. AND ANY of: i. Aortic Mean Gradient ≥ 40 mmHg ii. Aortic Peak Gradient ≥ 64 mmHg iii. Aortic Jet Velocity ≥ 4.0 m/s 3. POSSIBLE (Possible Aortic Stenosis but requires human review) a. Aortic Valve Area is NULL OR \>1.2 cm2 b. AND ANY of: i. Aortic Mean Gradient ≥ 40 mmHg ii. Aortic Peak Gradient ≥ 64 mmHg iii. Aortic Jet Velocity ≥ 4.0 m/s OR a. EITHER i. Aortic Valve Area ≤ 1.0 cm2 ii. Dimensionless Index ≤ 0.25 b. AND ALL are: i. Aortic Mean Gradient \< 15 mmHg ii. Aortic Peak Gradient \< 30 mmHg iii. Aortic Peak Velocity \< 2.75 m/s ALERT Study Clinical Investigation Plan Version 2.1 page 12 of 54 Any patient flagged for "POSSIBLE" does not result in automatically alerting the provider, instead a notification is sent to the Tempus research team for manual review in conjunction with the site Principal Investigator (PI) and if requested by Tempus or site PI, a Steering Committee member. If clinical confirmation is received for severe aortic stenosis from the site PI, an alert is sent to the provider. 1. Mitral Regurgitation a. Mention of severe mitral regurgitation or moderate- severe mitral regurgitation Any patient mentioned with only moderate MR or a lesser severity will be excluded. Exclusion Criteria: 1. Age \< 18 years 2. Patient had evidence of a prior transcatheter or surgical repair or replacement of the target valve 3. The echocardiogram was ordered by a cardiologist on the MHT or a cardiac surgeon 4. 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Bon Secours Mercy Health - Lima Market

    Lima, Ohio, 45801, United States

  • Bon Secours Mercy Health - Richmond Market

    Richmond, Virginia, 23223, United States

  • OhioHealth

    Columbus, Ohio, 43202, United States

  • Oregon Health and Science University

    Portland, Oregon, 97239, United States

  • Saint Luke's Health System

    Kansas City, Missouri, 64111, United States

  • Vanderbilt

    Nashville, Tennessee, 37235, United States

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