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Addressing Under-treatment and Health Equity in AS and MR Using an Integrated EHR Platform
NCT06099665 · View on ClinicalTrials.gov ↗
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. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 2,118 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Tempus AI, which has 12 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06099665 reports 6 study locations spanning 5 distinct geographic areas — top geographies include Ohio, Missouri, Oregon. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06099665?
The interventions under investigation include: Automated alert (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06099665?
This trial is sponsored by Tempus AI, which has 12 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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