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
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