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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: Completed NA study of Aortic Valve Stenosis and Mitral Regurgitation, sponsored by Tempus AI.
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. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
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 sched
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 |
What the finished NCT06099665 record still lists
NCT06099665 is an interventional study that assigns participants to a tested intervention. Its 2,118 participants enrollment target places it among the larger protocols in the corpus, above the 973-participant average among 30 other Aortic Valve Stenosis trials with a reported enrollment target (118% higher).
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 lists 6 locations in 5 states (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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Where NCT06099665's enrollment target sits among peer trials
2,118 4th of 30 higher than 27 of 30 other Aortic Valve Stenosis trials
participants (enrollment target), bucketed by value
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