Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

RECRUITING

Addressing Under-treatment and Health Equity in AS and MR Using an Integrated EHR Platform

Lead Sponsor:

Tempus AI

Collaborating Sponsors:

Medtronic

Conditions:

Aortic Valve Stenosis

Mitral Regurgitation

Eligibility:

All Genders

18+ years

Phase:

NA

Brief 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 i...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

    Key Trial Info

    Start Date :

    August 27 2024

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    December 1 2025

    Estimated Enrollment :

    2626 Patients enrolled

    Trial Details

    Trial ID

    NCT06099665

    Start Date

    August 27 2024

    End Date

    December 1 2025

    Last Update

    May 1 2025

    Active Locations (6)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 2 (6 locations)

    1

    Saint Luke's Health System

    Kansas City, Missouri, United States, 64111

    2

    OhioHealth

    Columbus, Ohio, United States, 43202

    3

    Bon Secours Mercy Health - Lima Market

    Lima, Ohio, United States, 45801

    4

    Oregon Health and Science University

    Portland, Oregon, United States, 97239