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NCT07103057Recruiting

VIZ ACCESS HCM - Multi-Site Registry

Viz.ai, Inc.

Start Date

6/13/2025

Completion Date

12/1/2028

Summary

To describe the clinical, economic, and population characteristics of newly diagnosed, previously diagnosed, and suspected patients evaluated by Viz HCM. HCM is underdiagnosed in the community and AI algorithms have been developed as screening tools. However, it is not well understood how to best integrate AI screening tools and their potential impact.

Eligibility Criteria

Age Range: 18 years to No maximum

All Cohorts * Patients aged 18+ years at time of arrival to healthcare facility * Patients with a resting 12-lead digital electrocardiogram (ECG) that is flagged by Viz HCM for HCM suspicion Additional cohort-specific criteria: Cohort 1 - Newly Diagnosed Patients * Patients have been diagnosed with HCM after the Viz HCM implementation * Written informed consent is obtained prior to data collection Cohort 2 - Previously Diagnosed Patients ● Prior diagnosis of HCM as evidenced by clinical diagnosis documentation prior to Viz HCM implementation Cohort 3 - Suspected and Not Diagnosed Patients ● Patients did not receive sufficient clinical workup for HCM diagnosis confirmation Cohort 4 - Unlikely HCM ● Patient ECG moved to 'Unlikely HCM' group within Viz by site study staff following HCM alert review Cohort 5 - Alerts Not Reviewed ● HCM alert not reviewed by site study staff during study enrollment period

Interventions

DEVICE

Viz HCM

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Conditions

Hypertrophic Cardiomyopathy

Locations

Emory University

Atlanta, Georgia 30322

United States

North Shore University Health System

Evanston, Illinois 60201

United States

Thomas Jefferson University

Philadelphia, Pennsylvania 19107

United States