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CompletedNo phase

Addressing Under-treatment and Health Equity in AS and MR Using an Integrated EHR Platform

Key facts

Who runs it
Tempus AI
Where
Columbus, Kansas City, Lima, Nashville, Portland, and Richmond, United StatesSee the 6 sites
Trial code
Status
Completed
People taking part
2,118 people enrolled
Started
27 Aug 2024
Ended
1 Dec 2025
Type of study
Interventional, 2 groupsOne group gets no study treatment, for comparison.
Treatments tested
  • Automated alert
Record updated
6 March 2026

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 9 criteriaShow less

Who cannot take part

  • Patient had evidence of a prior transcatheter or surgical repair or replacement of the target valve
  • 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
  • The echocardiogram was ordered by a cardiologist on the MHT or a cardiac surgeon
  • Age < 18 years

Other criteria

  • At least one of the following three options for aortic stenosis and/or the single option for mitral regurgitation are determined from echocardiogram findings:
  • 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); 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
  • AVA + OTHER (Patients with AVA and at least 1 other echo measurement in their echo above the threshold); 1.0 cm2 < Aortic Valve Area ≤ 1.2 cm2; AND ANY of:; Aortic Mean Gradient ≥ 40 mmHg ii. Aortic Peak Gradient ≥ 64 mmHg iii. Aortic Jet Velocity ≥ 4.0 m/s
  • 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
  • Mention of severe mitral regurgitation or moderate- severe mitral regurgitation; Any patient mentioned with only moderate MR or a lesser severity will be excluded

Where in United States

  • OhioHealthColumbus, United StatesNo longer taking part
  • Saint Luke's Health SystemKansas City, United StatesNo longer taking part
  • Bon Secours Mercy Health - Lima MarketLima, United StatesNo longer taking part
  • VanderbiltNashville, United StatesNo longer taking part
  • Oregon Health and Science UniversityPortland, United StatesNo longer taking part
  • Bon Secours Mercy Health - Richmond MarketRichmond, United StatesNo longer taking part

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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).

The 2 groups in the trial

  • Automated alertTreatment being tested

    Providers that will receive an automated alert sent via the EHR.

  • ControlNo study treatment, for comparison

    Care providers in the control arm will not receive an automated alert.

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Addressing Under-treatment and Health Equity in Aortic Stenosis and Mitral Regurgitation Using an Integrated EHR Platform
Publications
Record updated
6 March 2026