CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 2,118 enrolled
Drug / intervention
Automated alertbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06099665
NCT06099665N/ACompleted

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

Tempus AI·interventional·Posted Oct 25, 2023·Updated Mar 6, 2026

In Brief

A clinical study evaluating Automated alert for Aortic Valve Stenosis and Mitral Regurgitation. Completed, enrolled 2,118 participants across 6 sites.

Detailed 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). 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 Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsMedtronic

Timeline

N/ACompletedFinished
202420252026
First PostedOct 25, 2023
Enrollment StartAug 27, 2024
Primary CompletionDec 1, 2025
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 2.7 years ago

Interventions

Automated alertbehavioral

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.