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NCT06099665 · ClinicalTrials.gov registry record · NA
Addressing Under-treatment and Health Equity in AS and MR Using an Integrated EHR Platform
A NA study of Aortic Valve Stenosis and Mitral Regurgitation, sponsored by Tempus AI.
- Completed
- Registry status
- NA
- Development phase
- 2,118
- Enrollment target
- 6
- Study locations
NCT06099665 is a NA study of Aortic Valve Stenosis and Mitral Regurgitation that has completed, run by Tempus AI. The registered enrollment target is 2,118 participants, above the 973-participant average among 30 other Aortic Valve Stenosis trials with a reported enrollment target (118% higher). The trial reports 6 study locations across 5 states.
The verdict
NCT06099665, a NA study of Aortic Valve Stenosis and Mitral Regurgitation, has completed, sponsored by Tempus AI.
- COMPLETED
- Registry status
- NA
- Development phase
- 2,118 participants
- Enrollment target
- 6
- Study locations
Study 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).
Conditions Studied
Interventions
- BEHAVIORAL Automated alert
Study Locations (6)
Ohio
- OhioHealth - Columbus
- Bon Secours Mercy Health - Lima Market - Lima
Missouri
- Saint Luke's Health System - Kansas City
Oregon
- Oregon Health and Science University - Portland
Tennessee
- Vanderbilt - Nashville
Virginia
- Bon Secours Mercy Health - Richmond Market - Richmond
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,118 participants |
| Start Date | 2024-08-27 |
| Est. Completion | 2025-12-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06099665
The ClinicalTrials.gov registry entry for NCT06099665 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 2,118 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 973-participant average among 30 other Aortic Valve Stenosis trials with a reported enrollment target (118% higher). The listed sponsor is Tempus AI, which has 13 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Aortic Valve Stenosis appearing as the primary indexed condition, and to 1 intervention - of which Automated alert is the first listed.
NCT06099665 reports 6 study locations spanning 5 distinct geographic areas - top geographies include Ohio, Missouri, Oregon.
Frequently Asked Questions
What is clinical trial NCT06099665 about?
NCT06099665 is a clinical study titled "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...
What is the current status of trial NCT06099665?
This trial is currently completed. It is a NA study. The enrollment target is 2,118 participants. The study started on 2024-08-27. Estimated completion is 2025-12-01.
What conditions does trial NCT06099665 study?
This clinical trial studies the following conditions: Aortic Valve Stenosis, Mitral Regurgitation.
What interventions are being tested in trial NCT06099665?
The interventions under investigation include: Automated alert (BEHAVIORAL).
Who is sponsoring clinical trial NCT06099665?
This trial is sponsored by Tempus AI, which has 13 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06099665 being conducted?
This trial has 6 study locations across Missouri, Ohio, Oregon, Tennessee, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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