Completed

NCT Number: NCT06099665

Addressing Under-treatment and Health Equity in AS and MR 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:

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).

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Key information

Conditions

Aortic Valve Stenosis Aortic Valve Disease Cardiovascular Diseases Heart Diseases Heart Valve Diseases Mitral Regurgitation Mitral Valve Insufficiency Ventricular Outflow Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Saint Luke's Health System, Kansas City, Missouri, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

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

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:

i. 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

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

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.

Treatment and study plan

Automated alert

Behavioral

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.

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Tempus AI

Industry

Collaborators

Medtronic

Registry information

Official study title

Addressing Under-treatment and Health Equity in Aortic Stenosis and Mitral Regurgitation Using an Integrated EHR Platform

Acronym: ALERT

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Oct 25, 2023
Registry last updated: Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed